Grounding Effect on Alzheimer's Disease
Primary Purpose
Alzheimer Disease, Insomnia, Depression, Anxiety
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Grounding
Sponsored by
About this trial
This is an interventional supportive care trial for Alzheimer Disease
Eligibility Criteria
Inclusion Criteria:
- diagnosed with dementia, and CDR ≥ 0.5
- aged > 50 years,
- sit with bilateral bare feet on the grounding mat
- able to answer the questionnaire
- able to sign the informed consent adequately.
Exclusion Criteria:
- aged less than 50 years
- inability to sit with bilateral bare feet on the grounding mat
- currently taking anti-oxidative health supplements or anti-inflammatory medicine.
Sites / Locations
- Kaohsiung Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Patient receive grounding
Patient receive sham-grounding
Arm Description
The investigators use the grounding mat (EARTHING Conductive Earthing Uni-versal Mat with Earthing Cord) as the grounding method. The grounding group use a grounding wire to sit on a chair barefoot in contact with the grounding mat for 30 minutes.
The investigators use the grounding mat (EARTHING Conductive Earthing Uni-versal Mat with Earthing Cord) as the grounding method. The sham-grounding group use a sham grounding wire to sit on a chair barefoot in contact with the grounding mat for 30 minutes.
Outcomes
Primary Outcome Measures
The Pittsburgh Sleep Quality Index (PSQI) questionnaire for insomnia, score range from 0 to 21, the higher score means worse sleep quality
The investigators measure Pittsburgh Sleep Quality Index (PSQI) score before the patients participate the study (week 0, baseline data). After receiving 12 weeks grounding, the investigators measure PSQI again (week 12, post grounding data).
The Beck Anxiety Inventory (BAI) questionnaire for anxiety, score range from 0 to 63, the higher score means more anxiety the patient is.
The investigators measure Beck Anxiety Inventory (BAI) score before the patients participate the study (week 0, baseline data). After receiving 12 weeks grounding, the investigators measure BAI again (week 12, post grounding data).
The Beck Depression Inventory-II (BDI-II) questionnaire for depression, score range from 0 to 63, the higher score means more depression the patient is.
The investigators measure Beck Depression Inventory-II (BDI-II) score before the patients participate the study (week 0, baseline data). After receiving 12 weeks grounding, the investigators measure BDI-II again (week 12, post grounding data).
The electric current
The electrochemical analyzer CHI 1205b is a device that can measure the electric current via reduction-oxidation reaction.
The investigators measure the electric current before the patients participate the study (week 0, baseline data). After receiving 12 weeks grounding, the investigators measure the electric current again (week 12, post grounding data).
Secondary Outcome Measures
Full Information
NCT ID
NCT05246332
First Posted
February 9, 2022
Last Updated
February 9, 2022
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05246332
Brief Title
Grounding Effect on Alzheimer's Disease
Official Title
Grounding the Body Improves Sleep Quality in Patients With Mild Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
August 12, 2019 (Actual)
Study Completion Date
July 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The investigators explore the effectiveness of grounding as a non-pharmacological therapy for treating sleep disturbances, anxiety, and depression in patients with mild AD.
Detailed Description
Grounding refers to having direct contact with the Earth, such as walking barefoot or lying on the ground. Research has found that grounding can improve inflammation, free radical damage, blood pressure, sleep quality, pain, stress, mood, and wound healing. However, there has been no re-search on the effect of utilizing grounding for patients with Alzheimer's disease (AD). Thus, in this study, the investigators explore the effectiveness of grounding as a non-pharmacological therapy for treating sleep disturbances, anxiety, and depression in patients with mild AD.
Patients with mild AD were enrolled in the study. The electrochemical analyzer CHI 1205b was employed to check the electrochemical signals at acupoints KI1 and GV16. The investigators used the Pittsburgh Sleep Quality Index (PSQI), Beck Anxiety Inventory (BAI), and Beck Depression Inventory-II (BDI-II) to evaluate sleep quality, anxiety, and depression, respectively, at weeks 0 and 12.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Insomnia, Depression, Anxiety
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The investigators use a grounding wire and a sham grounding wire to create grounding and sham-grounding groups. The patients are blinded to the grounding because they do not know which one has a grounding effect according to the exterior of the mat.
The investigators who do the evaluation of questionnaire and electrochemical analyzer and the outcomes assessor who interpret the data do not know which wire has grounding effect, too.
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient receive grounding
Arm Type
Experimental
Arm Description
The investigators use the grounding mat (EARTHING Conductive Earthing Uni-versal Mat with Earthing Cord) as the grounding method. The grounding group use a grounding wire to sit on a chair barefoot in contact with the grounding mat for 30 minutes.
Arm Title
Patient receive sham-grounding
Arm Type
Sham Comparator
Arm Description
The investigators use the grounding mat (EARTHING Conductive Earthing Uni-versal Mat with Earthing Cord) as the grounding method. The sham-grounding group use a sham grounding wire to sit on a chair barefoot in contact with the grounding mat for 30 minutes.
Intervention Type
Device
Intervention Name(s)
Grounding
Intervention Description
The investigators used a grounding wire and a sham grounding wire to create grounding and sham-grounding groups. Participants sat on a chair barefoot in contact with the grounding mat for 30 minutes. The participants were blinded to the grounding because they did not know which one had a grounding effect according to the exterior of the mat.
Primary Outcome Measure Information:
Title
The Pittsburgh Sleep Quality Index (PSQI) questionnaire for insomnia, score range from 0 to 21, the higher score means worse sleep quality
Description
The investigators measure Pittsburgh Sleep Quality Index (PSQI) score before the patients participate the study (week 0, baseline data). After receiving 12 weeks grounding, the investigators measure PSQI again (week 12, post grounding data).
Time Frame
through study completion, an average of 12 weeks.
Title
The Beck Anxiety Inventory (BAI) questionnaire for anxiety, score range from 0 to 63, the higher score means more anxiety the patient is.
Description
The investigators measure Beck Anxiety Inventory (BAI) score before the patients participate the study (week 0, baseline data). After receiving 12 weeks grounding, the investigators measure BAI again (week 12, post grounding data).
Time Frame
through study completion, an average of 12 weeks.
Title
The Beck Depression Inventory-II (BDI-II) questionnaire for depression, score range from 0 to 63, the higher score means more depression the patient is.
Description
The investigators measure Beck Depression Inventory-II (BDI-II) score before the patients participate the study (week 0, baseline data). After receiving 12 weeks grounding, the investigators measure BDI-II again (week 12, post grounding data).
Time Frame
through study completion, an average of 12 weeks.
Title
The electric current
Description
The electrochemical analyzer CHI 1205b is a device that can measure the electric current via reduction-oxidation reaction.
The investigators measure the electric current before the patients participate the study (week 0, baseline data). After receiving 12 weeks grounding, the investigators measure the electric current again (week 12, post grounding data).
Time Frame
through study completion, an average of 12 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosed with dementia, and CDR ≥ 0.5
aged > 50 years,
sit with bilateral bare feet on the grounding mat
able to answer the questionnaire
able to sign the informed consent adequately.
Exclusion Criteria:
aged less than 50 years
inability to sit with bilateral bare feet on the grounding mat
currently taking anti-oxidative health supplements or anti-inflammatory medicine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nai-Ching Chen, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31831261
Citation
Menigoz W, Latz TT, Ely RA, Kamei C, Melvin G, Sinatra D. Integrative and lifestyle medicine strategies should include Earthing (grounding): Review of research evidence and clinical observations. Explore (NY). 2020 May-Jun;16(3):152-160. doi: 10.1016/j.explore.2019.10.005. Epub 2019 Nov 14.
Results Reference
background
PubMed Identifier
31855161
Citation
Figueiro MG, Plitnick B, Roohan C, Sahin L, Kalsher M, Rea MS. Effects of a Tailored Lighting Intervention on Sleep Quality, Rest-Activity, Mood, and Behavior in Older Adults With Alzheimer Disease and Related Dementias: A Randomized Clinical Trial. J Clin Sleep Med. 2019 Dec 15;15(12):1757-1767. doi: 10.5664/jcsm.8078. Epub 2019 Nov 8.
Results Reference
background
PubMed Identifier
27656022
Citation
Whitney MS, Shemery AM, Yaw AM, Donovan LJ, Glass JD, Deneris ES. Adult Brain Serotonin Deficiency Causes Hyperactivity, Circadian Disruption, and Elimination of Siestas. J Neurosci. 2016 Sep 21;36(38):9828-42. doi: 10.1523/JNEUROSCI.1469-16.2016.
Results Reference
background
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Grounding Effect on Alzheimer's Disease
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