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The Grounded Brain: How Sleeping Grounded Affects Memory and Perceptions

Primary Purpose

Mild Cognitive Impairment, Chronic Inflammation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
grounding mat
Sponsored by
California Institute of Integral Studies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mild Cognitive Impairment focused on measuring Earthing, systemic chronic inflammation, grounding, SCI, immune system, sleep quality, mood, pain, well-being, mild cognitive impairment due to Alzheimer's disease, MCI, glucocorticoid resistance, neurodegenerative, Cogstate Cognitive Brief Battery, Cogstate CBB

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All approved participants must

    1. Be at least 55 years of age; all genders and ethnicities;
    2. Have English as their primary language or be able to speak, read, and write English fluently; As this is a vulnerable population, this investigator must be able to evaluate understanding and cannot reliably do that with someone who is not fluent in English;
    3. Have a current diagnosis of mild cognitive impairment due to Alzheimer's disease made by a medical doctor;
    4. Be able to spend at least 6 hours per 24-hour period sleeping or resting on the grounded mat;
    5. Be able to legally consent to participating in this study;
    6. Agree to allow the researcher to come into their home to setup the equipment and administer the tests;
    7. Be able to see well enough to use a laptop to complete electronic testing;
    8. Be alert and oriented X 4 based on initial verbal screening and in-person visits;
    9. Reside in or around the Greater Austin, Texas, area/Central Texas area;
    10. Sleep in a dwelling that is grounded.

Exclusion Criteria:

  • All approved participants must

    1. Not have a diagnosis or conversion to AD or any other type of memory disorder before or during the study period including but not limited to dementia, Lewy body disease, Creutzfeldt-Jakob disease, Parkinson's disease, Huntington's disease, vascular cognitive impairment, frontotemporal dementias, primary progressive aphasia, autoimmune encephalopathy, and normal pressure hydrocephalus;
    2. Not have a diagnosis of stable MCI;
    3. Not have any prior diagnosis of traumatic brain injury;
    4. Not have any history of grounding consistently for more than 60 minutes/day in the past year. This includes natural methods and the use of any grounding devices;
    5. Not have any in-the-moment assessment that leads the investigator to believe that the participant is not fully aware or does not understand what is being asked of them. Again, this is a vulnerable population, and I will exclude or cut any participant who shows signs of confusion;
    6. Not be taking or have taken in the previous 30 days any of the following medications:

      1. daily anti-inflammatories, prescription or over the counter;
      2. blood pressure medications (anti-hypertensives);
      3. blood thinners (anti-coagulants);

      e. glucose control medications; f. thyroid medications; g. anti-convulsive medications (no matter the diagnosis); h. any type of monoclonal antibody; i. any type of immunosuppressive, including steroids; j. any type of immunomodulator.

    7. Inability to answer the questions in the initial screening interview;
    8. Inability to follow instructions.

A Note About Medications and Grounding:

Earthing has been proven to reduce inflammation, thin the blood, lower blood pressure, lower and better regulate glucose levels, and improve thyroid function. While all those things are generally sought after, there could be dire consequences if a participant is on a medication to correct any of those conditions, so in the interest of safety, exclusion based on certain medications is necessary. In that same vein, if any participant must begin a medication during the study period, that participant will be disqualified in the interest of safety.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Grounded

    Arm Description

    All participants will sleep on a grounding mat for at least six hours per 24-hour period.

    Outcomes

    Primary Outcome Measures

    Baseline Psychomotor Function Score
    In this simple reaction time Detection test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up (revealing a Joker card - this same card is used throughout the test). The subject is asked to press the "YES" button as soon as the card turns face-up. Assessed at baseline then weekly for three weeks.
    Week 1 Psychomotor Function Score
    In this simple reaction time Detection test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up (revealing a Joker card - this same card is used throughout the test). The subject is asked to press the "YES" button as soon as the card turns face-up. Assessed at baseline then weekly for three weeks.
    Week 2 Psychomotor Function Score
    In this simple reaction time Detection test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up (revealing a Joker card - this same card is used throughout the test). The subject is asked to press the "YES" button as soon as the card turns face-up. Assessed at baseline then weekly for three weeks.
    Week 3 Psychomotor Function Score
    In this simple reaction time Detection test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up (revealing a Joker card - this same card is used throughout the test). The subject is asked to press the "YES" button as soon as the card turns face-up. Assessed at baseline then weekly for three weeks.
    Change from Baseline to Week 3 Psychomotor Function Score
    In this simple reaction time Detection test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up (revealing a Joker card - this same card is used throughout the test). The subject is asked to press the "YES" button as soon as the card turns face-up. Assessed at baseline then weekly for three weeks. Change = (Week 3 Psychomotor Function Score - Baseline Psychomotor Function Score).
    Baseline Attention Score
    In this choice reaction time Identification test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. Either a red Joker card or black Joker card will be revealed. As soon as the card turns face-up, the subject decides whether the card displayed is red. If the card is red, the subject should press the "YES" button, if it is not red, they should press "NO". Assessed at baseline then weekly for three weeks.
    Week 1 Attention Score
    In this choice reaction time Identification test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. Either a red Joker card or black Joker card will be revealed. As soon as the card turns face-up, the subject decides whether the card displayed is red. If the card is red, the subject should press the "YES" button, if it is not red, they should press "NO". Assessed at baseline then weekly for three weeks.
    Week 2 Attention Score
    In this choice reaction time Identification test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. Either a red Joker card or black Joker card will be revealed. As soon as the card turns face-up, the subject decides whether the card displayed is red. If the card is red, the subject should press the "YES" button, if it is not red, they should press "NO". Assessed at baseline then weekly for three weeks.
    Week 3 Attention Score
    In this choice reaction time Identification test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. Either a red Joker card or black Joker card will be revealed. As soon as the card turns face-up, the subject decides whether the card displayed is red. If the card is red, the subject should press the "YES" button, if it is not red, they should press "NO". Assessed at baseline then weekly for three weeks.
    Change from Baseline to Week 3 Attention Score
    In this choice reaction time Identification test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. Either a red Joker card or black Joker card will be revealed. As soon as the card turns face-up, the subject decides whether the card displayed is red. If the card is red, the subject should press the "YES" button, if it is not red, they should press "NO". Assessed at baseline then weekly for three weeks. Change = (Week 3 Attention Score - Baseline Attention Score).
    Baseline Visual Learning Score
    In this pattern separation One Card Learning test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card has been seen before in the test. The subject should press the "YES" button if they have seen the card before in the test, or "NO" if they have not. Assessed at baseline then weekly for three weeks.
    Week 1 Visual Learning Score
    In this pattern separation One Card Learning test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card has been seen before in the test. The subject should press the "YES" button if they have seen the card before in the test, or "NO" if they have not. Assessed at baseline then weekly for three weeks.
    Week 2 Visual Learning Score
    In this pattern separation One Card Learning test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card has been seen before in the test. The subject should press the "YES" button if they have seen the card before in the test, or "NO" if they have not. Assessed at baseline then weekly for three weeks.
    Week 3 Visual Learning Score
    In this pattern separation One Card Learning test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card has been seen before in the test. The subject should press the "YES" button if they have seen the card before in the test, or "NO" if they have not. Assessed at baseline then weekly for three weeks.
    Change from Baseline to Week 3 Visual Learning Score
    In this pattern separation One Card Learning test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card has been seen before in the test. The subject should press the "YES" button if they have seen the card before in the test, or "NO" if they have not. Assessed at baseline then weekly for three weeks. Change = (Week 3 Visual Learning Score - Baseline Visual Learning Score).
    Baseline Working Memory Score
    In this N-back One Back test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card is the same as the previous card. The subject should press the "YES" button if the current card is the same as the one presented immediately before it, or "NO" if it is not the same. Assessed at baseline and weekly for three weeks.
    Week 1 Working Memory Score
    In this N-back One Back test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card is the same as the previous card. The subject should press the "YES" button if the current card is the same as the one presented immediately before it, or "NO" if it is not the same. Assessed at baseline and weekly for three weeks.
    Week 2 Working Memory Score
    In this N-back One Back test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card is the same as the previous card. The subject should press the "YES" button if the current card is the same as the one presented immediately before it, or "NO" if it is not the same. Assessed at baseline and weekly for three weeks.
    Week 3 Working Memory Score
    In this N-back One Back test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card is the same as the previous card. The subject should press the "YES" button if the current card is the same as the one presented immediately before it, or "NO" if it is not the same. Assessed at baseline and weekly for three weeks.
    Change from Baseline to Week 3 Working Memory Score
    In this N-back One Back test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card is the same as the previous card. The subject should press the "YES" button if the current card is the same as the one presented immediately before it, or "NO" if it is not the same. Assessed at baseline and weekly for three weeks. Change = (Week 3 Working Memory Score - Baseline Working Memory Score).
    Baseline Sleep Quality Score
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about sleep quality while the second question about sleep quality is scaled. Possible scores range from 0 (worst sleep quality) to 10 (best sleep quality).
    Week 1 Sleep Quality Score
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about sleep quality while the second question about sleep quality is scaled. Possible scores range from 0 (worst sleep quality) to 10 (best sleep quality).
    Week 2 Sleep Quality Score
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about sleep quality while the second question about sleep quality is scaled. Possible scores range from 0 (worst sleep quality) to 10 (best sleep quality).
    Week 3 Sleep Quality Score
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about sleep quality while the second question about sleep quality is scaled. Possible scores range from 0 (worst sleep quality) to 10 (best sleep quality).
    Change from Baseline to Week 3 Sleep Quality Score
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about sleep quality while the second question about sleep quality is scaled. Possible scores range from 0 (worst sleep quality) to 10 (best sleep quality). Change = (Week 3 Sleep Quality Score - Baseline Sleep Quality Score).
    Baseline Pain Score
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about pain while the second question about pain is scaled. Possible scores range from 0 (no pain) to 10 (worst pain).
    Week 1 Pain Score
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about pain while the second question about pain is scaled. Possible scores range from 0 (no pain) to 10 (worst pain).
    Week 2 Pain Score
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about pain while the second question about pain is scaled. Possible scores range from 0 (no pain) to 10 (worst pain).
    Week 3 Pain Score
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about pain while the second question about pain is scaled. Possible scores range from 0 (no pain) to 10 (worst pain).
    Change from Baseline to Week 3 Pain Score
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about pain while the second question about pain is scaled. Possible scores range from 0 (no pain) to 10 (worst pain).
    Baseline Mood Score
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about mood while the second question about mood is scaled. Possible scores range from 0 (worst mood) to 10 (best mood).
    Week 1 Mood Score
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about mood while the second question about mood is scaled. Possible scores range from 0 (worst mood) to 10 (best mood).
    Week 2 Mood Score
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about mood while the second question about mood is scaled. Possible scores range from 0 (worst mood) to 10 (best mood).
    Week 3 Mood Score
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about mood while the second question about mood is scaled. Possible scores range from 0 (worst mood) to 10 (best mood).
    Change from Baseline to Week 3 Mood Score
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about mood while the second question about mood is scaled. Possible scores range from 0 (worst mood) to 10 (best mood).
    Baseline Overall Well-Being Score
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about overall well-being while the second question about overall well-being is scaled. Possible scores range from 0 (worst overall well-being) to 10 (best overall well-being).
    Week 1 Overall Well-Being Score
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about overall well-being while the second question about overall well-being is scaled. Possible scores range from 0 (worst overall well-being) to 10 (best overall well-being).
    Week 2 Overall Well-Being Score
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about overall well-being while the second question about overall well-being is scaled. Possible scores range from 0 (worst overall well-being) to 10 (best overall well-being).
    Week 3 Overall Well-Being Score
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about overall well-being while the second question about overall well-being is scaled. Possible scores range from 0 (worst overall well-being) to 10 (best overall well-being).
    Change from Baseline to Week 3 Overall Well-Being Score
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about overall well-being while the second question about overall well-being is scaled. Possible scores range from 0 (worst overall well-being) to 10 (best overall well-being).

    Secondary Outcome Measures

    Correlation of Change in Psychomotor Function Score and Sleep Quality Score from Baseline to Week 3
    Using simple regression to assess Baseline to Week 3 change in Psychomotor Function Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Sleep Quality Score.
    Correlation of Change in Psychomotor Function Score and Pain Score from Baseline to Week 3
    Using simple regression to assess Baseline to Week 3 change in Psychomotor Function Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Pain Score.
    Correlation of Change in Psychomotor Function Score and Mood Score from Baseline to Week 3
    Using simple regression to assess Baseline to Week 3 change in Psychomotor Function Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Mood Score.
    Correlation of Change in Psychomotor Function Score and Overall Well-Being Score from Baseline to Week 3
    Using simple regression to assess Baseline to Week 3 change in Psychomotor Function Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Overall Well-Being Score.
    Correlation of Change in Attention Score and Sleep Quality Score from Baseline to Week 3
    Using simple regression to assess Baseline to Week 3 change in Attention Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Sleep Quality Score.
    Correlation of Change in Attention Score and Pain Score from Baseline to Week 3
    Using simple regression to assess Baseline to Week 3 change in Attention Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Pain Score.
    Correlation of Change in Attention Score and Mood Score from Baseline to Week 3
    Using simple regression to assess Baseline to Week 3 change in Attention Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Mood Score.
    Correlation of Change in Attention Score and Overall Well-Being Score from Baseline to Week 3
    Using simple regression to assess Baseline to Week 3 change in Attention Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Overall Well-Being Score.
    Correlation of Change in Visual Learning Score and Sleep Quality Score from Baseline to Week 3
    Using simple regression to assess Baseline to Week 3 change in Visual Learning Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Sleep Quality Score.
    Correlation of Change in Visual Learning Score and Pain Score from Baseline to Week 3
    Using simple regression to assess Baseline to Week 3 change in Visual Learning Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Pain Score.
    Correlation of Change in Visual Learning Score and Mood Score from Baseline to Week 3
    Using simple regression to assess Baseline to Week 3 change in Visual Learning Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Mood Score.
    Correlation of Change in Visual Learning Score and Overall Well-Being Score from Baseline to Week 3
    Using simple regression to assess Baseline to Week 3 change in Visual Learning Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Overall Well-Being Score.
    Correlation of Change in Working Memory Score and Sleep Quality Score from Baseline to Week 3
    Using simple regression to assess Baseline to Week 3 change in Working Memory Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Sleep Quality Score.
    Correlation of Change in Working Memory Score and Pain Score from Baseline to Week 3
    Using simple regression to assess Baseline to Week 3 change in Working Memory Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Pain Score.
    Correlation of Change in Working Memory Score and Mood Score from Baseline to Week 3
    Using simple regression to assess Baseline to Week 3 change in Working Memory Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Mood Score.
    Correlation of Change in Working Memory Score and Overall Well-Being Score from Baseline to Week 3
    Using simple regression to assess Baseline to Week 3 change in Working Memory Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Overall Well-Being Score.

    Full Information

    First Posted
    September 10, 2021
    Last Updated
    September 20, 2021
    Sponsor
    California Institute of Integral Studies
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05050812
    Brief Title
    The Grounded Brain: How Sleeping Grounded Affects Memory and Perceptions
    Official Title
    The Grounded Brain: How Sleeping Grounded (Earthing) Affects Cognition and Personal Perceptions in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (MCI/AD)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2021 (Anticipated)
    Primary Completion Date
    November 2021 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    California Institute of Integral Studies

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Grounding (Earthing) refers to the practice of contacting the Earth or a properly installed grounding mat with the body. Previous studies on grounding have shown positive effects body-wide inflammation, acute and chronic pain, and immune system response. Prior studies on the inflammatory process of mild cognitive impairment due to Alzheimer's disease, Alzheimer's disease, and some other dementias have shown connections between immune system dysregulation, inflammatory markers, and severe disease progression. Finding ways to mitigate or turn off the inflammatory response is key to treating mild cognitive impairment due to Alzheimer's disease. The purpose of this study is to evaluate the effects of sleeping grounded on cognition and personal perceptions in participants with a diagnosis of mild cognitive impairment due to Alzheimer's disease as evidenced by a battery of assessments using Cogstate's Cognitive Brief Battery and a qualitative questionnaire. We hypothesize that assessment scores will improve with grounding and that perceptions will positively correlate with an increase in scores. Modulation of risk factors like glucocorticoid resistance, SCI, and immune system dysfunction through grounding may lead to an accessible, natural technique for neurodegenerative disease prevention or treatment.
    Detailed Description
    Grounding (Earthing) refers to the practice of contacting the Earth or a properly installed grounding mat with the body. Previous studies on grounding have shown positive effects on diurnal cortisol regulation, systemic chronic inflammation (SCI), immune system response, acute and chronic pain, mood, vagal tone, blood viscosity, blood flow, recovery from muscle strain and damage, and prevention or mitigation of chronic inflammatory and autoimmune diseases. Prior studies on the inflammatory process of mild cognitive impairment due to Alzheimer's disease, Alzheimer's disease, and some other dementias have shown connections between immune system dysregulation, inflammatory markers, and severe disease progression. The purpose of this study is to evaluate the effects of sleeping grounded on cognition and personal perceptions in participants with a diagnosis of mild cognitive impairment due to Alzheimer's disease (MCI/AD) as evidenced by a battery of tests using the Cogstate platform's Cognitive Brief Battery (CBB) and a qualitative questionnaire to detect any correlations to the participant's perceptions of sleep quality, mood, pain, and overall well-being. This study will both fulfill the requirement for a Bachelor of Science in Psychology and lay the foundation for further research into grounding and neurodegenerative diseases. My senior research project methodology is a mixed methods research design with a triangulation convergence, since I'll be concurrently collecting, analyzing, and evaluating the results of the quantitative and qualitative measurements before comparing, integrating, and interpreting the outcomes. I have three hypotheses. First, I hypothesize that sleeping while grounded will result in improved scores on the Cogstate battery of tests given at baseline and weekly for three weeks. Second, I hypothesize that sleeping while grounded will result in positive perceptions regarding sleep quality, mood, pain, and overall well-being. Finally, I hypothesize that improved Cogstate scores will positively correlate with perceptions of sleep quality, mood, and overall well-being and negatively correlate with pain. The independent variable is the intervention (grounded sleeping mat), and the dependent variables are the three measurements of cognition (memory, working memory, and processing speed) and the qualitative questionnaire to evaluate how the participants feel about their sleep quality, mood, pain, and overall well-being. The target population for this study will be adults aged 55 and up (N=8) with a current diagnosis of MCI/AD who meet the inclusion and exclusion criteria. I will employ a mixed methods research design that includes statistical analysis of empirical data and a qualitative questionnaire. I will use a triangulation convergence, since I'll be concurrently collecting, analyzing, and evaluating the results of the quantitative and qualitative measurements before comparing, integrating, and interpreting the outcomes. First, I will look at the percentage of change in each testing area from week to week and calculate the statistical significance (p < .01) of any changes. Second, I will calculate the mean of all the test scores per day (baseline and weekly X 3) to obtain a general cognition score which I will also use to calculate statistical significance (p < .01) of changes over time. Third, I will perform a simple linear regression analysis to determine if a correlation exists between the intervention and the cognition scores after baseline. Finally, I will perform an analysis of the qualitative questionnaire using in vivo coding to determine if any correlations exist between the cognition scores and personal perceptions. For this study, I will interpret the results based on changes in test scores over time, changes in general cognition scores over time, and positive/negative correlations of the personal perceptions and cognition scores. Each participant will receive an Earthing Elite™ sleep mat kit which they get to keep. The sleeping mat will be installed wherever the participant sleeps (bed or recliner), and I will ensure that the mat is properly attached to the grounding plug and confirm grounding using a multimeter with two terminal leads, a cord with alligator clips on both ends, an Earthing coil cord, and an outlet checker. This procedure will show body voltage prior to grounding and while grounding to confirm that the setup is working and that body voltage has been neutralized. I will return for repeat assessments after one week, two weeks, and three weeks at which time I will verify that the system is still working properly. All computerized testing will consist of the following assessments on the Cogstate platform: 1) Detection test (psychomotor function); 2) Identification test (attention); 3) One Card Learning test (visual learning); and 4) One Back test (working memory). The personal perceptions qualitative questionnaire will consist of several open-ended and scaled questions designed to assess how the participants perceive various subjective areas such as sleep quality, pain, mood, and overall well-being. Each participant will complete the questionnaire first before completing the computerized cognition assessments. Modulation of risk factors like glucocorticoid resistance, SCI, and immune system dysfunction through grounding may lead to an accessible, natural technique for neurodegenerative disease prevention or treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mild Cognitive Impairment, Chronic Inflammation
    Keywords
    Earthing, systemic chronic inflammation, grounding, SCI, immune system, sleep quality, mood, pain, well-being, mild cognitive impairment due to Alzheimer's disease, MCI, glucocorticoid resistance, neurodegenerative, Cogstate Cognitive Brief Battery, Cogstate CBB

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    An interventional, single-group method that lacks random assignment and has no control group but does provide baseline and post-intervention testing.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    8 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Grounded
    Arm Type
    Experimental
    Arm Description
    All participants will sleep on a grounding mat for at least six hours per 24-hour period.
    Intervention Type
    Device
    Intervention Name(s)
    grounding mat
    Other Intervention Name(s)
    Earthing mat
    Intervention Description
    Participants will sleep on an Earthing Elite sleep mat produced and sold by Earthing.com
    Primary Outcome Measure Information:
    Title
    Baseline Psychomotor Function Score
    Description
    In this simple reaction time Detection test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up (revealing a Joker card - this same card is used throughout the test). The subject is asked to press the "YES" button as soon as the card turns face-up. Assessed at baseline then weekly for three weeks.
    Time Frame
    Baseline
    Title
    Week 1 Psychomotor Function Score
    Description
    In this simple reaction time Detection test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up (revealing a Joker card - this same card is used throughout the test). The subject is asked to press the "YES" button as soon as the card turns face-up. Assessed at baseline then weekly for three weeks.
    Time Frame
    Week 1
    Title
    Week 2 Psychomotor Function Score
    Description
    In this simple reaction time Detection test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up (revealing a Joker card - this same card is used throughout the test). The subject is asked to press the "YES" button as soon as the card turns face-up. Assessed at baseline then weekly for three weeks.
    Time Frame
    Week 2
    Title
    Week 3 Psychomotor Function Score
    Description
    In this simple reaction time Detection test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up (revealing a Joker card - this same card is used throughout the test). The subject is asked to press the "YES" button as soon as the card turns face-up. Assessed at baseline then weekly for three weeks.
    Time Frame
    Week 3
    Title
    Change from Baseline to Week 3 Psychomotor Function Score
    Description
    In this simple reaction time Detection test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up (revealing a Joker card - this same card is used throughout the test). The subject is asked to press the "YES" button as soon as the card turns face-up. Assessed at baseline then weekly for three weeks. Change = (Week 3 Psychomotor Function Score - Baseline Psychomotor Function Score).
    Time Frame
    Change from baseline to week 3
    Title
    Baseline Attention Score
    Description
    In this choice reaction time Identification test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. Either a red Joker card or black Joker card will be revealed. As soon as the card turns face-up, the subject decides whether the card displayed is red. If the card is red, the subject should press the "YES" button, if it is not red, they should press "NO". Assessed at baseline then weekly for three weeks.
    Time Frame
    Baseline
    Title
    Week 1 Attention Score
    Description
    In this choice reaction time Identification test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. Either a red Joker card or black Joker card will be revealed. As soon as the card turns face-up, the subject decides whether the card displayed is red. If the card is red, the subject should press the "YES" button, if it is not red, they should press "NO". Assessed at baseline then weekly for three weeks.
    Time Frame
    Week 1
    Title
    Week 2 Attention Score
    Description
    In this choice reaction time Identification test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. Either a red Joker card or black Joker card will be revealed. As soon as the card turns face-up, the subject decides whether the card displayed is red. If the card is red, the subject should press the "YES" button, if it is not red, they should press "NO". Assessed at baseline then weekly for three weeks.
    Time Frame
    Week 2
    Title
    Week 3 Attention Score
    Description
    In this choice reaction time Identification test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. Either a red Joker card or black Joker card will be revealed. As soon as the card turns face-up, the subject decides whether the card displayed is red. If the card is red, the subject should press the "YES" button, if it is not red, they should press "NO". Assessed at baseline then weekly for three weeks.
    Time Frame
    Week 3
    Title
    Change from Baseline to Week 3 Attention Score
    Description
    In this choice reaction time Identification test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. Either a red Joker card or black Joker card will be revealed. As soon as the card turns face-up, the subject decides whether the card displayed is red. If the card is red, the subject should press the "YES" button, if it is not red, they should press "NO". Assessed at baseline then weekly for three weeks. Change = (Week 3 Attention Score - Baseline Attention Score).
    Time Frame
    Baseline to week 4
    Title
    Baseline Visual Learning Score
    Description
    In this pattern separation One Card Learning test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card has been seen before in the test. The subject should press the "YES" button if they have seen the card before in the test, or "NO" if they have not. Assessed at baseline then weekly for three weeks.
    Time Frame
    Baseline
    Title
    Week 1 Visual Learning Score
    Description
    In this pattern separation One Card Learning test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card has been seen before in the test. The subject should press the "YES" button if they have seen the card before in the test, or "NO" if they have not. Assessed at baseline then weekly for three weeks.
    Time Frame
    Week 1
    Title
    Week 2 Visual Learning Score
    Description
    In this pattern separation One Card Learning test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card has been seen before in the test. The subject should press the "YES" button if they have seen the card before in the test, or "NO" if they have not. Assessed at baseline then weekly for three weeks.
    Time Frame
    Week 2
    Title
    Week 3 Visual Learning Score
    Description
    In this pattern separation One Card Learning test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card has been seen before in the test. The subject should press the "YES" button if they have seen the card before in the test, or "NO" if they have not. Assessed at baseline then weekly for three weeks.
    Time Frame
    Week 3
    Title
    Change from Baseline to Week 3 Visual Learning Score
    Description
    In this pattern separation One Card Learning test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card has been seen before in the test. The subject should press the "YES" button if they have seen the card before in the test, or "NO" if they have not. Assessed at baseline then weekly for three weeks. Change = (Week 3 Visual Learning Score - Baseline Visual Learning Score).
    Time Frame
    Baseline to Week 3
    Title
    Baseline Working Memory Score
    Description
    In this N-back One Back test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card is the same as the previous card. The subject should press the "YES" button if the current card is the same as the one presented immediately before it, or "NO" if it is not the same. Assessed at baseline and weekly for three weeks.
    Time Frame
    Baseline
    Title
    Week 1 Working Memory Score
    Description
    In this N-back One Back test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card is the same as the previous card. The subject should press the "YES" button if the current card is the same as the one presented immediately before it, or "NO" if it is not the same. Assessed at baseline and weekly for three weeks.
    Time Frame
    Week 1
    Title
    Week 2 Working Memory Score
    Description
    In this N-back One Back test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card is the same as the previous card. The subject should press the "YES" button if the current card is the same as the one presented immediately before it, or "NO" if it is not the same. Assessed at baseline and weekly for three weeks.
    Time Frame
    Week 2
    Title
    Week 3 Working Memory Score
    Description
    In this N-back One Back test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card is the same as the previous card. The subject should press the "YES" button if the current card is the same as the one presented immediately before it, or "NO" if it is not the same. Assessed at baseline and weekly for three weeks.
    Time Frame
    Week 3
    Title
    Change from Baseline to Week 3 Working Memory Score
    Description
    In this N-back One Back test, a playing card is presented face-down in the center of the screen. After a random interval, the card will turn over so that is it face-up. A regular playing card from a French deck is revealed. As soon as the card turns face-up, the subject must decide whether the current card is the same as the previous card. The subject should press the "YES" button if the current card is the same as the one presented immediately before it, or "NO" if it is not the same. Assessed at baseline and weekly for three weeks. Change = (Week 3 Working Memory Score - Baseline Working Memory Score).
    Time Frame
    Baseline and Week 3
    Title
    Baseline Sleep Quality Score
    Description
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about sleep quality while the second question about sleep quality is scaled. Possible scores range from 0 (worst sleep quality) to 10 (best sleep quality).
    Time Frame
    Baseline
    Title
    Week 1 Sleep Quality Score
    Description
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about sleep quality while the second question about sleep quality is scaled. Possible scores range from 0 (worst sleep quality) to 10 (best sleep quality).
    Time Frame
    Week 1
    Title
    Week 2 Sleep Quality Score
    Description
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about sleep quality while the second question about sleep quality is scaled. Possible scores range from 0 (worst sleep quality) to 10 (best sleep quality).
    Time Frame
    Week 2
    Title
    Week 3 Sleep Quality Score
    Description
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about sleep quality while the second question about sleep quality is scaled. Possible scores range from 0 (worst sleep quality) to 10 (best sleep quality).
    Time Frame
    Week 3
    Title
    Change from Baseline to Week 3 Sleep Quality Score
    Description
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about sleep quality while the second question about sleep quality is scaled. Possible scores range from 0 (worst sleep quality) to 10 (best sleep quality). Change = (Week 3 Sleep Quality Score - Baseline Sleep Quality Score).
    Time Frame
    Week 3
    Title
    Baseline Pain Score
    Description
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about pain while the second question about pain is scaled. Possible scores range from 0 (no pain) to 10 (worst pain).
    Time Frame
    Baseline
    Title
    Week 1 Pain Score
    Description
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about pain while the second question about pain is scaled. Possible scores range from 0 (no pain) to 10 (worst pain).
    Time Frame
    Week 1
    Title
    Week 2 Pain Score
    Description
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about pain while the second question about pain is scaled. Possible scores range from 0 (no pain) to 10 (worst pain).
    Time Frame
    Week 2
    Title
    Week 3 Pain Score
    Description
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about pain while the second question about pain is scaled. Possible scores range from 0 (no pain) to 10 (worst pain).
    Time Frame
    Week 3
    Title
    Change from Baseline to Week 3 Pain Score
    Description
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about pain while the second question about pain is scaled. Possible scores range from 0 (no pain) to 10 (worst pain).
    Time Frame
    Baseline to Week 3
    Title
    Baseline Mood Score
    Description
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about mood while the second question about mood is scaled. Possible scores range from 0 (worst mood) to 10 (best mood).
    Time Frame
    Baseline
    Title
    Week 1 Mood Score
    Description
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about mood while the second question about mood is scaled. Possible scores range from 0 (worst mood) to 10 (best mood).
    Time Frame
    Week 1
    Title
    Week 2 Mood Score
    Description
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about mood while the second question about mood is scaled. Possible scores range from 0 (worst mood) to 10 (best mood).
    Time Frame
    Week 2
    Title
    Week 3 Mood Score
    Description
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about mood while the second question about mood is scaled. Possible scores range from 0 (worst mood) to 10 (best mood).
    Time Frame
    Week 3
    Title
    Change from Baseline to Week 3 Mood Score
    Description
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about mood while the second question about mood is scaled. Possible scores range from 0 (worst mood) to 10 (best mood).
    Time Frame
    Baseline to Week 3
    Title
    Baseline Overall Well-Being Score
    Description
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about overall well-being while the second question about overall well-being is scaled. Possible scores range from 0 (worst overall well-being) to 10 (best overall well-being).
    Time Frame
    Baseline
    Title
    Week 1 Overall Well-Being Score
    Description
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about overall well-being while the second question about overall well-being is scaled. Possible scores range from 0 (worst overall well-being) to 10 (best overall well-being).
    Time Frame
    Week 1
    Title
    Week 2 Overall Well-Being Score
    Description
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about overall well-being while the second question about overall well-being is scaled. Possible scores range from 0 (worst overall well-being) to 10 (best overall well-being).
    Time Frame
    Week 2
    Title
    Week 3 Overall Well-Being Score
    Description
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about overall well-being while the second question about overall well-being is scaled. Possible scores range from 0 (worst overall well-being) to 10 (best overall well-being).
    Time Frame
    Week 3
    Title
    Change from Baseline to Week 3 Overall Well-Being Score
    Description
    The Personal Perceptions Questionnaire is a self-designed instrument assessing a participant's perception about their average sleep quality, mood, pain, and well-being over the past 7 days. One question is open-ended and uses in vivo coding to create a score about overall well-being while the second question about overall well-being is scaled. Possible scores range from 0 (worst overall well-being) to 10 (best overall well-being).
    Time Frame
    Baseline to Week 3
    Secondary Outcome Measure Information:
    Title
    Correlation of Change in Psychomotor Function Score and Sleep Quality Score from Baseline to Week 3
    Description
    Using simple regression to assess Baseline to Week 3 change in Psychomotor Function Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Sleep Quality Score.
    Time Frame
    Baseline to Week 3
    Title
    Correlation of Change in Psychomotor Function Score and Pain Score from Baseline to Week 3
    Description
    Using simple regression to assess Baseline to Week 3 change in Psychomotor Function Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Pain Score.
    Time Frame
    Baseline to Week 3
    Title
    Correlation of Change in Psychomotor Function Score and Mood Score from Baseline to Week 3
    Description
    Using simple regression to assess Baseline to Week 3 change in Psychomotor Function Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Mood Score.
    Time Frame
    Baseline to Week 3
    Title
    Correlation of Change in Psychomotor Function Score and Overall Well-Being Score from Baseline to Week 3
    Description
    Using simple regression to assess Baseline to Week 3 change in Psychomotor Function Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Overall Well-Being Score.
    Time Frame
    Baseline to Week 3
    Title
    Correlation of Change in Attention Score and Sleep Quality Score from Baseline to Week 3
    Description
    Using simple regression to assess Baseline to Week 3 change in Attention Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Sleep Quality Score.
    Time Frame
    Baseline to Week 3
    Title
    Correlation of Change in Attention Score and Pain Score from Baseline to Week 3
    Description
    Using simple regression to assess Baseline to Week 3 change in Attention Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Pain Score.
    Time Frame
    Baseline to Week 3
    Title
    Correlation of Change in Attention Score and Mood Score from Baseline to Week 3
    Description
    Using simple regression to assess Baseline to Week 3 change in Attention Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Mood Score.
    Time Frame
    Baseline to Week 3
    Title
    Correlation of Change in Attention Score and Overall Well-Being Score from Baseline to Week 3
    Description
    Using simple regression to assess Baseline to Week 3 change in Attention Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Overall Well-Being Score.
    Time Frame
    Baseline to Week 3
    Title
    Correlation of Change in Visual Learning Score and Sleep Quality Score from Baseline to Week 3
    Description
    Using simple regression to assess Baseline to Week 3 change in Visual Learning Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Sleep Quality Score.
    Time Frame
    Baseline to Week 3
    Title
    Correlation of Change in Visual Learning Score and Pain Score from Baseline to Week 3
    Description
    Using simple regression to assess Baseline to Week 3 change in Visual Learning Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Pain Score.
    Time Frame
    Baseline to Week 3
    Title
    Correlation of Change in Visual Learning Score and Mood Score from Baseline to Week 3
    Description
    Using simple regression to assess Baseline to Week 3 change in Visual Learning Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Mood Score.
    Time Frame
    Baseline to Week 3
    Title
    Correlation of Change in Visual Learning Score and Overall Well-Being Score from Baseline to Week 3
    Description
    Using simple regression to assess Baseline to Week 3 change in Visual Learning Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Overall Well-Being Score.
    Time Frame
    Baseline to Week 3
    Title
    Correlation of Change in Working Memory Score and Sleep Quality Score from Baseline to Week 3
    Description
    Using simple regression to assess Baseline to Week 3 change in Working Memory Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Sleep Quality Score.
    Time Frame
    Baseline to Week 3
    Title
    Correlation of Change in Working Memory Score and Pain Score from Baseline to Week 3
    Description
    Using simple regression to assess Baseline to Week 3 change in Working Memory Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Pain Score.
    Time Frame
    Baseline to Week 3
    Title
    Correlation of Change in Working Memory Score and Mood Score from Baseline to Week 3
    Description
    Using simple regression to assess Baseline to Week 3 change in Working Memory Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Mood Score.
    Time Frame
    Baseline to Week 3
    Title
    Correlation of Change in Working Memory Score and Overall Well-Being Score from Baseline to Week 3
    Description
    Using simple regression to assess Baseline to Week 3 change in Working Memory Score and whether that change positively or negatively correlates to the Change from Baseline to Week 3 Overall Well-Being Score.
    Time Frame
    Baseline to Week 3

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All approved participants must Be at least 55 years of age; all genders and ethnicities; Have English as their primary language or be able to speak, read, and write English fluently; As this is a vulnerable population, this investigator must be able to evaluate understanding and cannot reliably do that with someone who is not fluent in English; Have a current diagnosis of mild cognitive impairment due to Alzheimer's disease made by a medical doctor; Be able to spend at least 6 hours per 24-hour period sleeping or resting on the grounded mat; Be able to legally consent to participating in this study; Agree to allow the researcher to come into their home to setup the equipment and administer the tests; Be able to see well enough to use a laptop to complete electronic testing; Be alert and oriented X 4 based on initial verbal screening and in-person visits; Reside in or around the Greater Austin, Texas, area/Central Texas area; Sleep in a dwelling that is grounded. Exclusion Criteria: All approved participants must Not have a diagnosis or conversion to AD or any other type of memory disorder before or during the study period including but not limited to dementia, Lewy body disease, Creutzfeldt-Jakob disease, Parkinson's disease, Huntington's disease, vascular cognitive impairment, frontotemporal dementias, primary progressive aphasia, autoimmune encephalopathy, and normal pressure hydrocephalus; Not have a diagnosis of stable MCI; Not have any prior diagnosis of traumatic brain injury; Not have any history of grounding consistently for more than 60 minutes/day in the past year. This includes natural methods and the use of any grounding devices; Not have any in-the-moment assessment that leads the investigator to believe that the participant is not fully aware or does not understand what is being asked of them. Again, this is a vulnerable population, and I will exclude or cut any participant who shows signs of confusion; Not be taking or have taken in the previous 30 days any of the following medications: daily anti-inflammatories, prescription or over the counter; blood pressure medications (anti-hypertensives); blood thinners (anti-coagulants); e. glucose control medications; f. thyroid medications; g. anti-convulsive medications (no matter the diagnosis); h. any type of monoclonal antibody; i. any type of immunosuppressive, including steroids; j. any type of immunomodulator. Inability to answer the questions in the initial screening interview; Inability to follow instructions. A Note About Medications and Grounding: Earthing has been proven to reduce inflammation, thin the blood, lower blood pressure, lower and better regulate glucose levels, and improve thyroid function. While all those things are generally sought after, there could be dire consequences if a participant is on a medication to correct any of those conditions, so in the interest of safety, exclusion based on certain medications is necessary. In that same vein, if any participant must begin a medication during the study period, that participant will be disqualified in the interest of safety.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Patrice F Jones, CPC
    Phone
    (512) 762-1864
    Email
    pfjones@mymail.ciis.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Patrice F Jones, CPC
    Organizational Affiliation
    California Institute of Integral Studies
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Anne Huffman, PhD
    Organizational Affiliation
    California Institute of Integral Studies
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33814444
    Citation
    Bostrom G, Freyhult E, Virhammar J, Alcolea D, Tumani H, Otto M, Brundin RM, Kilander L, Lowenmark M, Giedraitis V, Lleo A, von Arnim CAF, Kultima K, Ingelsson M. Different Inflammatory Signatures in Alzheimer's Disease and Frontotemporal Dementia Cerebrospinal Fluid. J Alzheimers Dis. 2021;81(2):629-640. doi: 10.3233/JAD-201565.
    Results Reference
    result
    PubMed Identifier
    20192911
    Citation
    Brown D, Chevalier G, Hill M. Pilot study on the effect of grounding on delayed-onset muscle soreness. J Altern Complement Med. 2010 Mar;16(3):265-73. doi: 10.1089/acm.2009.0399.
    Results Reference
    result
    PubMed Identifier
    27454187
    Citation
    Brown R. Effects of Grounding on Body Voltage and Current in the Presence of Electromagnetic Fields. J Altern Complement Med. 2016 Sep;22(9):757-9. doi: 10.1089/acm.2015.0340. Epub 2016 Jul 25.
    Results Reference
    result
    PubMed Identifier
    26443876
    Citation
    Brown R, Chevalier G, Hill M. Grounding after moderate eccentric contractions reduces muscle damage. Open Access J Sports Med. 2015 Sep 21;6:305-17. doi: 10.2147/OAJSM.S87970. eCollection 2015.
    Results Reference
    result
    PubMed Identifier
    20064020
    Citation
    Chevalier G. Changes in pulse rate, respiratory rate, blood oxygenation, perfusion index, skin conductance, and their variability induced during and after grounding human subjects for 40 minutes. J Altern Complement Med. 2010 Jan;16(1):81-7. doi: 10.1089/acm.2009.0278.
    Results Reference
    result
    PubMed Identifier
    25748085
    Citation
    Chevalier G. The effect of grounding the human body on mood. Psychol Rep. 2015 Apr;116(2):534-42. doi: 10.2466/06.PR0.116k21w5. Epub 2015 Mar 6.
    Results Reference
    result
    PubMed Identifier
    30448083
    Citation
    Chevalier G, Patel S, Weiss L, Chopra D, Mills PJ. The Effects of Grounding (Earthing) on Bodyworkers' Pain and Overall Quality of Life: A Randomized Controlled Trial. Explore (NY). 2019 May-Jun;15(3):181-190. doi: 10.1016/j.explore.2018.10.001. Epub 2018 Oct 11.
    Results Reference
    result
    PubMed Identifier
    22757749
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    Links:
    URL
    https://earthinginstitute.net/wp-content/uploads/2018/10/beware-of-earthing-misinformation-2018.pdf
    Description
    "Beware of Misinformation" from The Earthing Institute
    URL
    https://earthinginstitute.net/wp-content/uploads/2020/06/How-to-Measure-the-Effect-of-Earthing-on-Body-Voltage-2020.pdf
    Description
    "How to Measure the Effect of Earthing on Body Voltage" from The Earthing Institute
    URL
    https://earthinginstitute.net/the-magic-pain-patches-every-medicine-cabinet-should-have-them/
    Description
    "Grounding Pain Patches: Every Medicine Cabinet Should Have Them" from The Earthing Institute
    URL
    https://earthinginstitute.net/medical-and-medication-considerations/
    Description
    "Medical and Medication Considerations" from The Earthing Institute

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    The Grounded Brain: How Sleeping Grounded Affects Memory and Perceptions

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