Back to resultsPhase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients
Primary Purpose
Mild Cognitive Impairment
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Circadian-Effective Light
Rhythmic Light
Placebo Light
Placebo Rhythmic Light
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Light Treatment, Circadian Rhythms, Gamma Wave Entrainment, Rhythmic Light, Sleep, Cognition
Eligibility Criteria
Inclusion Criteria:
- Participants must be diagnosed with amnestic mild cognitive impairment or mild Alzheimer's disease, as defined by a Montreal Cognitive Assessment score between 17 and 25;
- Have sleep disturbance indicated by a score >5 on the Pittsburgh Sleep Quality Index
- Sleep efficiency < 80% assessed by wearing an actigraph for 3 days
- Participants must reside in their homes, independent living, or assisted living facilities
Exclusion Criteria:
- Participants taking sleep medication
- Presence of another brain disease that fully explains the dementia (extensive brain vascular disease, Parkin-son's disease, dementia with Lewy bodies, traumatic brain injury, or multiple sclerosis)
- Residence in a skilled nursing facility or long-term care
- Major organ failure (e.g., kidney failure)
- Uncontrolled generalized disorders such as hypertension or diabetes
- Obstructing cataracts, macular degeneration, and blindness
- Severe sleep apnea or restless leg syndrome
- History of severe epilepsy
Sites / Locations
- Light and Health Research CenterRecruiting
- Icahn School of Medicine at Mount SinaiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Active Intervention plus Active Rhythm
Active Light plus Placebo Rhythm
Placebo Light plus Active Rhythm
Placebo Light plus Placebo Rhythm
Arm Description
The device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time.
The device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time.
The device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time.
The device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time.
Outcomes
Primary Outcome Measures
Cognition using the Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment is a one-page, 30-point test that can be administered in 10 minutes. It assesses short-term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language, and orientation to time and place. total score ranging from 0 to 30 units on a scale, with higher score indicating better cognitive global function.
Cognition using the Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment is a one-page, 30-point test that can be administered in 10 minutes. It assesses short-term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language, and orientation to time and place. total score ranging from 0 to 30 units on a scale, with higher score indicating better cognitive global function.
Cognition using the Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment is a one-page, 30-point test that can be administered in 10 minutes. It assesses short-term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language, and orientation to time and place. total score ranging from 0 to 30 units on a scale, with higher score indicating better cognitive global function.
Secondary Outcome Measures
Cognition using a working memory task
Participants view a serial visual display of letters and math problems. They are asked to hold the letters in memory while simultaneously determining if the simple math problems are correct (e.g., 7+5=13). Math performance is measured in percent correct and verbal performance is assessed by calculating Accuracy and Reaction Time (RT).
Cognition using a working memory task
Participants view a serial visual display of letters and math problems. They are asked to hold the letters in memory while simultaneously determining if the simple math problems are correct (e.g., 7+5=13). Math performance is measured in percent correct and verbal performance is assessed by calculating Accuracy and Reaction Time (RT).
Cognition using a working memory task
Participants view a serial visual display of letters and math problems. They are asked to hold the letters in memory while simultaneously determining if the simple math problems are correct (e.g., 7+5=13). Math performance is measured in percent correct and verbal performance is assessed by calculating Accuracy and Reaction Time (RT).
Cognition using a word pair associates task
Participants are presented with 48 word-pairs in the evening. Recognition tests are assessed both immediately following the encoding session, and delayed during retrieval.
Cognition using a word pair associates task
Participants are presented with 48 word-pairs in the evening. Recognition tests are assessed both immediately following the encoding session, and delayed during retrieval.
Cognition using a word pair associates task
Participants are presented with 48 word-pairs in the evening. Recognition tests are assessed both immediately following the encoding session, and delayed during retrieval.
Cognition using an implicit priming task
Participants will be presented with simple pictures of objects and animals. Following a break, the participant will then be asked to identify a larger set of pictures as soon as he/she is able to do so as the pictures clarify over time; some of these test pictures were shown previously and some are new.
Cognition using an implicit priming task
Participants will be presented with simple pictures of objects and animals. Following a break, the participant will then be asked to identify a larger set of pictures as soon as he/she is able to do so as the pictures clarify over time; some of these test pictures were shown previously and some are new.
Cognition using an implicit priming task
Participants will be presented with simple pictures of objects and animals. Following a break, the participant will then be asked to identify a larger set of pictures as soon as he/she is able to do so as the pictures clarify over time; some of these test pictures were shown previously and some are new.
Cognition using the Alzheimer's Disease Assessment Scale - Cognitive Subscale
This interview-style test assesses multiple cognitive domains such as memory, language, praxis, and orientation. The ADAS-Cog subscale is scored from 0-100. The full ADAS is scored from 0 to 150 by summing the number of errors made on each task so that higher scores indicate worse performance.
Cognition using the Alzheimer's Disease Assessment Scale - Cognitive Subscale
This interview-style test assesses multiple cognitive domains such as memory, language, praxis, and orientation. The Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) subscale is scored from 0-100. The full ADAS is scored from 0 to 150 by summing the number of errors made on each task so that higher scores indicate worse performance.
Cognition using the Alzheimer's Disease Assessment Scale - Cognitive Subscale
This interview-style test assesses multiple cognitive domains such as memory, language, praxis, and orientation. The ADAS-Cog subscale is scored from 0-100. The full ADAS is scored from 0 to 150 by summing the number of errors made on each task so that higher scores indicate worse performance.
Urine Melatonin Biomarker
Urine Melatonin Biomarker via urine collection
Urine Melatonin Biomarker
Urine Melatonin Biomarker via urine collection
Light Exposure using a Daysimeter
The Daysimeter will also be used to monitor the total amount of circadian light received by the participant during the study.
Light Exposure using a Daysimeter
The Daysimeter will also be used to monitor the total amount of circadian light received by the participant during the study.
Light Exposure using a Daysimeter
The Daysimeter will also be used to monitor the total amount of circadian light received by the participant during the study.
Sleep Quantity using Actigraphy
Sleep Quantity measured using Actigraphy
Sleep Quantity using Actigraphy
Sleep Quantity measured using Actigraphy
Sleep Quantity using Actigraphy
Sleep Quantity measured using Actigraphy
Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index is a tool that can be used to measure sleep quality in clinical populations, composed of 19 items that generate 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, with higher score indicates worse sleep quality
Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index is a tool that can be used to measure sleep quality in clinical populations, composed of 19 items that generate 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, with higher score indicates worse sleep quality
Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index is a tool that can be used to measure sleep quality in clinical populations, composed of 19 items that generate 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, with higher score indicates worse sleep quality
Quality of Life using the Dementia Quality of Life Instrument
The Dementia Quality of Life Instrument (DQoL) measures self-esteem, positive affect/humor, negative affect, feelings of belonging, and sense of aesthetics.The DQoL consists of 29 items, grouped into 5 subscales according to domain. Subjects are instructed to answer using a 5-point response scale (score from 1-5), either verbally or through use of a visual scale. Scores for each subscale are Self-esteem (4-20), Positive Affect/Humor (6-30), Absence of Negative Affect (11-55), Feelings of Belonging (3-15), Sense of Aesthetics (5-25); however, subscale scores are not summed for a total score. A higher number indicates greater quality of life.
Quality of Life using the Dementia Quality of Life Instrument
The Dementia Quality of Life Instrument (DQoL) measures self-esteem, positive affect/humor, negative affect, feelings of belonging, and sense of aesthetics.The DQoL consists of 29 items, grouped into 5 subscales according to domain. Subjects are instructed to answer using a 5-point response scale (score from 1-5), either verbally or through use of a visual scale. Scores for each subscale are Self-esteem (4-20), Positive Affect/Humor (6-30), Absence of Negative Affect (11-55), Feelings of Belonging (3-15), Sense of Aesthetics (5-25); however, subscale scores are not summed for a total score. A higher number indicates greater quality of life.
Quality of Life using the Dementia Quality of Life Instrument
The Dementia Quality of Life Instrument (DQoL) measures self-esteem, positive affect/humor, negative affect, feelings of belonging, and sense of aesthetics.The DQoL consists of 29 items, grouped into 5 subscales according to domain. Subjects are instructed to answer using a 5-point response scale (score from 1-5), either verbally or through use of a visual scale. Scores for each subscale are Self-esteem (4-20), Positive Affect/Humor (6-30), Absence of Negative Affect (11-55), Feelings of Belonging (3-15), Sense of Aesthetics (5-25); however, subscale scores are not summed for a total score. A higher number indicates greater quality of life.
Full Information
NCT ID
NCT05016219
First Posted
August 12, 2021
Last Updated
September 12, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT05016219
Brief Title
Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients
Official Title
Phase 2 - The Use of Rhythmic Light Therapy to Entrain Gamma Oscillations and the Circadian System in Patients With Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 22, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
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
Participants will randomly be placed into one of four groups and experience one of the four following conditions: (1) a placebo light that provides a 40 hertz (Hz) flicker (rhythmic light [RL]); (2) a placebo light with a random flicker (placebo condition for rhythmic light); (3) a light source that will stimulate the circadian system and provides a 40 Hz flicker (RL); or (4) a light source that will stimulate the circadian system and provides a random flicker (placebo condition for rhythmic light). Following a baseline week, participants will experience his/her assigned lighting condition for two hours in the morning for 8 weeks. After a 4-week washout period, a final round of assessments will be obtained. Study assessments (except for the Pittsburgh Sleep Quality Index and Montreal Cognitive Assessment) will be collected at the end of each week, for a total of 8 assessments.
Detailed Description
The tailored lighting intervention used to promote circadian entrainment will provide high circadian stimulation during the day produced by narrowband blue light peaking at 470 nanometers (nm). A comparison lighting intervention (i.e., placebo lighting), a narrowband red light peaking at 630 nm, will be used as a control. Both the red and the blue light devices will also provide either the 40 hertz (Hz) flicker (RL) or the random flicker (placebo RL). For the random flicker (placebo RL), the duty cycle will be delivered with a random interval determined by a Poisson process with an average interval of 40 hertz (Hz).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Light Treatment, Circadian Rhythms, Gamma Wave Entrainment, Rhythmic Light, Sleep, Cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Intervention plus Active Rhythm
Arm Type
Active Comparator
Arm Description
The device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time.
Arm Title
Active Light plus Placebo Rhythm
Arm Type
Active Comparator
Arm Description
The device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time.
Arm Title
Placebo Light plus Active Rhythm
Arm Type
Active Comparator
Arm Description
The device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time.
Arm Title
Placebo Light plus Placebo Rhythm
Arm Type
Placebo Comparator
Arm Description
The device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time.
Intervention Type
Device
Intervention Name(s)
Circadian-Effective Light
Other Intervention Name(s)
Active Light
Intervention Description
Narrowband blue light
Intervention Type
Device
Intervention Name(s)
Rhythmic Light
Intervention Description
40 hertz (Hz) flicker
Intervention Type
Device
Intervention Name(s)
Placebo Light
Intervention Description
Narrowband red light
Intervention Type
Device
Intervention Name(s)
Placebo Rhythmic Light
Intervention Description
Random flicker for placebo rhythmic effect
Primary Outcome Measure Information:
Title
Cognition using the Montreal Cognitive Assessment (MoCA)
Description
The Montreal Cognitive Assessment is a one-page, 30-point test that can be administered in 10 minutes. It assesses short-term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language, and orientation to time and place. total score ranging from 0 to 30 units on a scale, with higher score indicating better cognitive global function.
Time Frame
baseline
Title
Cognition using the Montreal Cognitive Assessment (MoCA)
Description
The Montreal Cognitive Assessment is a one-page, 30-point test that can be administered in 10 minutes. It assesses short-term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language, and orientation to time and place. total score ranging from 0 to 30 units on a scale, with higher score indicating better cognitive global function.
Time Frame
at the end of week 9
Title
Cognition using the Montreal Cognitive Assessment (MoCA)
Description
The Montreal Cognitive Assessment is a one-page, 30-point test that can be administered in 10 minutes. It assesses short-term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language, and orientation to time and place. total score ranging from 0 to 30 units on a scale, with higher score indicating better cognitive global function.
Time Frame
at the end of week 14
Secondary Outcome Measure Information:
Title
Cognition using a working memory task
Description
Participants view a serial visual display of letters and math problems. They are asked to hold the letters in memory while simultaneously determining if the simple math problems are correct (e.g., 7+5=13). Math performance is measured in percent correct and verbal performance is assessed by calculating Accuracy and Reaction Time (RT).
Time Frame
baseline
Title
Cognition using a working memory task
Description
Participants view a serial visual display of letters and math problems. They are asked to hold the letters in memory while simultaneously determining if the simple math problems are correct (e.g., 7+5=13). Math performance is measured in percent correct and verbal performance is assessed by calculating Accuracy and Reaction Time (RT).
Time Frame
at the end of week 9
Title
Cognition using a working memory task
Description
Participants view a serial visual display of letters and math problems. They are asked to hold the letters in memory while simultaneously determining if the simple math problems are correct (e.g., 7+5=13). Math performance is measured in percent correct and verbal performance is assessed by calculating Accuracy and Reaction Time (RT).
Time Frame
at the end of week 14
Title
Cognition using a word pair associates task
Description
Participants are presented with 48 word-pairs in the evening. Recognition tests are assessed both immediately following the encoding session, and delayed during retrieval.
Time Frame
baseline
Title
Cognition using a word pair associates task
Description
Participants are presented with 48 word-pairs in the evening. Recognition tests are assessed both immediately following the encoding session, and delayed during retrieval.
Time Frame
at the end of week 9
Title
Cognition using a word pair associates task
Description
Participants are presented with 48 word-pairs in the evening. Recognition tests are assessed both immediately following the encoding session, and delayed during retrieval.
Time Frame
at the end of week 14.
Title
Cognition using an implicit priming task
Description
Participants will be presented with simple pictures of objects and animals. Following a break, the participant will then be asked to identify a larger set of pictures as soon as he/she is able to do so as the pictures clarify over time; some of these test pictures were shown previously and some are new.
Time Frame
baseline
Title
Cognition using an implicit priming task
Description
Participants will be presented with simple pictures of objects and animals. Following a break, the participant will then be asked to identify a larger set of pictures as soon as he/she is able to do so as the pictures clarify over time; some of these test pictures were shown previously and some are new.
Time Frame
at the end of week 9
Title
Cognition using an implicit priming task
Description
Participants will be presented with simple pictures of objects and animals. Following a break, the participant will then be asked to identify a larger set of pictures as soon as he/she is able to do so as the pictures clarify over time; some of these test pictures were shown previously and some are new.
Time Frame
at the end of week 14.
Title
Cognition using the Alzheimer's Disease Assessment Scale - Cognitive Subscale
Description
This interview-style test assesses multiple cognitive domains such as memory, language, praxis, and orientation. The ADAS-Cog subscale is scored from 0-100. The full ADAS is scored from 0 to 150 by summing the number of errors made on each task so that higher scores indicate worse performance.
Time Frame
baseline
Title
Cognition using the Alzheimer's Disease Assessment Scale - Cognitive Subscale
Description
This interview-style test assesses multiple cognitive domains such as memory, language, praxis, and orientation. The Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) subscale is scored from 0-100. The full ADAS is scored from 0 to 150 by summing the number of errors made on each task so that higher scores indicate worse performance.
Time Frame
at the end of week 9
Title
Cognition using the Alzheimer's Disease Assessment Scale - Cognitive Subscale
Description
This interview-style test assesses multiple cognitive domains such as memory, language, praxis, and orientation. The ADAS-Cog subscale is scored from 0-100. The full ADAS is scored from 0 to 150 by summing the number of errors made on each task so that higher scores indicate worse performance.
Time Frame
at the end of week 14.
Title
Urine Melatonin Biomarker
Description
Urine Melatonin Biomarker via urine collection
Time Frame
baseline
Title
Urine Melatonin Biomarker
Description
Urine Melatonin Biomarker via urine collection
Time Frame
at the end of week 9.
Title
Light Exposure using a Daysimeter
Description
The Daysimeter will also be used to monitor the total amount of circadian light received by the participant during the study.
Time Frame
baseline
Title
Light Exposure using a Daysimeter
Description
The Daysimeter will also be used to monitor the total amount of circadian light received by the participant during the study.
Time Frame
week 9
Title
Light Exposure using a Daysimeter
Description
The Daysimeter will also be used to monitor the total amount of circadian light received by the participant during the study.
Time Frame
week 14.
Title
Sleep Quantity using Actigraphy
Description
Sleep Quantity measured using Actigraphy
Time Frame
baseline
Title
Sleep Quantity using Actigraphy
Description
Sleep Quantity measured using Actigraphy
Time Frame
week 9
Title
Sleep Quantity using Actigraphy
Description
Sleep Quantity measured using Actigraphy
Time Frame
week 14
Title
Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI)
Description
The Pittsburgh Sleep Quality Index is a tool that can be used to measure sleep quality in clinical populations, composed of 19 items that generate 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, with higher score indicates worse sleep quality
Time Frame
baseline
Title
Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI)
Description
The Pittsburgh Sleep Quality Index is a tool that can be used to measure sleep quality in clinical populations, composed of 19 items that generate 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, with higher score indicates worse sleep quality
Time Frame
at the end of week 9
Title
Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI)
Description
The Pittsburgh Sleep Quality Index is a tool that can be used to measure sleep quality in clinical populations, composed of 19 items that generate 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, with higher score indicates worse sleep quality
Time Frame
at the end of week 14.
Title
Quality of Life using the Dementia Quality of Life Instrument
Description
The Dementia Quality of Life Instrument (DQoL) measures self-esteem, positive affect/humor, negative affect, feelings of belonging, and sense of aesthetics.The DQoL consists of 29 items, grouped into 5 subscales according to domain. Subjects are instructed to answer using a 5-point response scale (score from 1-5), either verbally or through use of a visual scale. Scores for each subscale are Self-esteem (4-20), Positive Affect/Humor (6-30), Absence of Negative Affect (11-55), Feelings of Belonging (3-15), Sense of Aesthetics (5-25); however, subscale scores are not summed for a total score. A higher number indicates greater quality of life.
Time Frame
baseline
Title
Quality of Life using the Dementia Quality of Life Instrument
Description
The Dementia Quality of Life Instrument (DQoL) measures self-esteem, positive affect/humor, negative affect, feelings of belonging, and sense of aesthetics.The DQoL consists of 29 items, grouped into 5 subscales according to domain. Subjects are instructed to answer using a 5-point response scale (score from 1-5), either verbally or through use of a visual scale. Scores for each subscale are Self-esteem (4-20), Positive Affect/Humor (6-30), Absence of Negative Affect (11-55), Feelings of Belonging (3-15), Sense of Aesthetics (5-25); however, subscale scores are not summed for a total score. A higher number indicates greater quality of life.
Time Frame
at the end of week 9
Title
Quality of Life using the Dementia Quality of Life Instrument
Description
The Dementia Quality of Life Instrument (DQoL) measures self-esteem, positive affect/humor, negative affect, feelings of belonging, and sense of aesthetics.The DQoL consists of 29 items, grouped into 5 subscales according to domain. Subjects are instructed to answer using a 5-point response scale (score from 1-5), either verbally or through use of a visual scale. Scores for each subscale are Self-esteem (4-20), Positive Affect/Humor (6-30), Absence of Negative Affect (11-55), Feelings of Belonging (3-15), Sense of Aesthetics (5-25); however, subscale scores are not summed for a total score. A higher number indicates greater quality of life.
Time Frame
at the end of week 14.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants must be diagnosed with mild cognitive impairment or mild Alzheimer's disease, as defined by a Montreal Cognitive Assessment score between 17 and 25;
Have sleep disturbance indicated by a score >5 on the Pittsburgh Sleep Quality Index
Participants must reside in their homes, independent living, or assisted living facilities
Exclusion Criteria:
Participants taking sleep medication
Residence in a skilled nursing facility or long-term care
Obstructing cataracts, macular degeneration, and blindness
Severe sleep apnea or restless leg syndrome
History of severe epilepsy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Plitnick, BSN
Phone
518-242-4603
Email
barbara.plitnick@mountsinai.org
First Name & Middle Initial & Last Name or Official Title & Degree
Mariana Figueiro, PhD
Phone
518-366-9306
Email
mariana.figueiro@mountsinai.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariana Figueiro, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Light and Health Research Center
City
Menands
State/Province
New York
ZIP/Postal Code
12204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Plitnick, BS
Phone
518-242-4603
Email
Barbara.Plitnick@mountsinai.org
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariana Figueiro, PhD
Phone
518-366-9306
Email
Mariana.Figueiro@mountsinai.org
12. IPD Sharing Statement
Citations:
PubMed Identifier
16216333
Citation
Rea MS, Figueiro MG, Bullough JD, Bierman A. A model of phototransduction by the human circadian system. Brain Res Brain Res Rev. 2005 Dec 15;50(2):213-28. doi: 10.1016/j.brainresrev.2005.07.002. Epub 2005 Oct 7. Erratum In: Brain Res Brain Res Rev. 2007 Nov;56(1):270.
Results Reference
background
PubMed Identifier
15817019
Citation
Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991.
Results Reference
background
PubMed Identifier
6496779
Citation
Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64. doi: 10.1176/ajp.141.11.1356.
Results Reference
background
PubMed Identifier
24443644
Citation
Figueiro MG, Hamner R, Bierman A, Rea MS. Comparisons of three practical field devices used to measure personal light exposures and activity levels. Light Res Technol. 2013 Aug;45(4):421-434. doi: 10.1177/1477153512450453.
Results Reference
background
PubMed Identifier
1947597
Citation
Buysse DJ, Reynolds CF 3rd, Monk TH, Hoch CC, Yeager AL, Kupfer DJ. Quantification of subjective sleep quality in healthy elderly men and women using the Pittsburgh Sleep Quality Index (PSQI). Sleep. 1991 Aug;14(4):331-8. Erratum In: Sleep 1992 Feb;15(1):83.
Results Reference
background
PubMed Identifier
7104545
Citation
Hughes CP, Berg L, Danziger WL, Coben LA, Martin RL. A new clinical scale for the staging of dementia. Br J Psychiatry. 1982 Jun;140:566-72. doi: 10.1192/bjp.140.6.566.
Results Reference
background
PubMed Identifier
2748771
Citation
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
Results Reference
background
PubMed Identifier
6610841
Citation
McKhann G, Drachman D, Folstein M, Katzman R, Price D, Stadlan EM. Clinical diagnosis of Alzheimer's disease: report of the NINCDS-ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer's Disease. Neurology. 1984 Jul;34(7):939-44. doi: 10.1212/wnl.34.7.939.
Results Reference
background
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Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients
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