Back to resultsRhythmic Light Therapy for Alzheimer's Disease Patients
Primary Purpose
Mild Cognitive Impairment
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tailored Rhythmic Lighting Intervention
Placebo Rhythmic Lighting Intervention
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, Mild Alzheimer's Disease, Sleep, Memory, Electroencephalogram
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 (MoCA) score between 17 and 25
- For the age-matched healthy controls, participants must not be diagnosed with mild cognitive impairment or Alzheimer's disease related dementias (MoCA score above 25).
- Participants must score a 5 or less in the Pittsburgh Sleep Quality Index (PSQI)
Exclusion Criteria:
- All participants must not be taking sleeping medication or oral melatonin
- Presence of another brain disease that fully explains the dementia (extensive brain vascular disease, Parkinson'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 epilepsy
Sites / Locations
- Light and Health Research Center
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active Tailored Rhythmic Lighting
Inactive Placebo Rhythmic Lighting
Arm Description
1 hour intervention period where active lighting is experienced by participants.
1 hour intervention period where an inactive, placebo lighting condition is experienced by participants.
Outcomes
Primary Outcome Measures
Electroencephalography (EEG) power at 40 hertz (Hz)
Electroencephalography (EEG) recordings, lasting 3-minutes each, will occur 2 times per experimental session. The power at 40 hertz (Hz), 4-8 Hz (theta), and 30-55 Hz (low gamma) frequency ranges will be calculated at each electrode site. Entrainment to the 40 Hz rhythmic stimulation will be assessed in terms of increases in power at 40 Hz.
Electroencephalography (EEG) power at 40 hertz (Hz)
Electroencephalography (EEG) recordings, lasting 3-minutes each, will occur 2 times per experimental session. The power at 40 hertz (Hz), 4-8 Hz (theta), and 30-55 Hz (low gamma) frequency ranges will be calculated at each electrode site. Entrainment to the 40 Hz rhythmic stimulation will be assessed in terms of increases in power at 40 Hz.
Secondary Outcome Measures
Subjective Sleepiness using the Karolinska Sleepiness Scale (KSS)
The Karolinska Sleepiness Scale (KSS) outcome prompts participants to rate how sleepy or alert they are feeling on a scale ranging from 1 to 9, where 1 = "very alert," 3 = "rather alert," 5 = "neither alert nor sleepy," 7 = "sleepy, but no difficulty remaining awake," and 9 = "very sleepy, fighting sleep, an effort to remain awake."
Subjective Sleepiness using the Karolinska Sleepiness Scale (KSS)
The Karolinska Sleepiness Scale (KSS) outcome prompts participants to rate how sleepy or alert they are feeling on a scale ranging from 1 to 9, where 1 = "very alert," 3 = "rather alert," 5 = "neither alert nor sleepy," 7 = "sleepy, but no difficulty remaining awake," and 9 = "very sleepy, fighting sleep, an effort to remain awake."
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). Performance is assessed in percent correct and by measuring 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). Performance is assessed in percent correct and by measuring accuracy and Reaction Time (RT).
Full Information
NCT ID
NCT05015478
First Posted
August 12, 2021
Last Updated
July 7, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT05015478
Brief Title
Rhythmic Light Therapy for Alzheimer's Disease Patients
Official Title
Phase 1 - 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
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
July 5, 2023 (Actual)
Study Completion Date
December 30, 2025 (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
The investigator will investigate how light delivering 40 hertz (Hz) affects subjective sleep and cognition in a controlled laboratory study. A lab study will allow the collection of electroencephalogram (EEG) data, perform cognitive tests, and observe the response in those with mild cognitive impairment (MCI) compared to a healthy control group (HC).
Participants will attend two study sessions over the course of two weeks. During both sessions, all participants will experience 10 minutes of a low-level light, followed by a data collection period which involves a sleepiness rating, an electroencephalogram (EEG) recording, and a computerized memory test. Participants will then experience either a RL or a placebo RL condition for one hour, after which there will be a second data collection.
Detailed Description
The investigator will demonstrate the effect of 40 hertz (Hz) rhythmic light (RL) to promote gamma wave entrainment (rhythmic light [RL]) on: brain response (electroencephalography [EEG]); cognitive performance (working memory task); and subjective sleepiness (questionnaires). The study will recruit 20 adult mild cognitive impairment (MCI) patients and 20 healthy, age-matched controls (HC) to participate in this study.
Sessions will initiate with a 10-minute adaptation period to a low-level ambient light providing illuminance of 15 lux at participants' eye level on a vertical plane, followed by a pre-exposure data collection period, including Karolinska Sleepiness Scale (KSS), EEG, and a working memory task. Participants will experience either 40 Hz RL or placebo RL conditions for a duration of 1 hour, followed by the second data collection period. On the second data collection day, participants will experience the other condition, so that all participants experience both lighting conditions. The experimental sessions will start at 14:00 on each experimental day which will be separated by 1 week.
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, Mild Alzheimer's Disease, Sleep, Memory, Electroencephalogram
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Tailored Rhythmic Lighting
Arm Type
Active Comparator
Arm Description
1 hour intervention period where active lighting is experienced by participants.
Arm Title
Inactive Placebo Rhythmic Lighting
Arm Type
Placebo Comparator
Arm Description
1 hour intervention period where an inactive, placebo lighting condition is experienced by participants.
Intervention Type
Device
Intervention Name(s)
Tailored Rhythmic Lighting Intervention
Intervention Description
40 hertz (Hz) rhythmic lighting (RL) for a duration of 1 hour. The flicker frequency of the 40 Hz RL will be 40 Hz and the stimulation will be a square wave with a 50 % duty cycle (i.e., 12.5 milliseconds light- on and 12.5 milliseconds light-off). The RL will provide a 30 lux of red light on a vertical plane at the eye level.
Intervention Type
Device
Intervention Name(s)
Placebo Rhythmic Lighting Intervention
Intervention Description
Placebo rhythmic light (RL) for a duration of 1 hour. In the placebo RL condition, the duty cycle will be delivered with a random interval determined by a Poisson process with an average interval of 40 hertz (Hz). The placebo RL conditions will provide a 30 lux of red light on a vertical plane at the eye level.
Primary Outcome Measure Information:
Title
Electroencephalography (EEG) power at 40 hertz (Hz)
Description
Electroencephalography (EEG) recordings, lasting 3-minutes each, will occur 2 times per experimental session. The power at 40 hertz (Hz), 4-8 Hz (theta), and 30-55 Hz (low gamma) frequency ranges will be calculated at each electrode site. Entrainment to the 40 Hz rhythmic stimulation will be assessed in terms of increases in power at 40 Hz.
Time Frame
baseline
Title
Electroencephalography (EEG) power at 40 hertz (Hz)
Description
Electroencephalography (EEG) recordings, lasting 3-minutes each, will occur 2 times per experimental session. The power at 40 hertz (Hz), 4-8 Hz (theta), and 30-55 Hz (low gamma) frequency ranges will be calculated at each electrode site. Entrainment to the 40 Hz rhythmic stimulation will be assessed in terms of increases in power at 40 Hz.
Time Frame
1 hour after intervention
Secondary Outcome Measure Information:
Title
Subjective Sleepiness using the Karolinska Sleepiness Scale (KSS)
Description
The Karolinska Sleepiness Scale (KSS) outcome prompts participants to rate how sleepy or alert they are feeling on a scale ranging from 1 to 9, where 1 = "very alert," 3 = "rather alert," 5 = "neither alert nor sleepy," 7 = "sleepy, but no difficulty remaining awake," and 9 = "very sleepy, fighting sleep, an effort to remain awake."
Time Frame
baseline
Title
Subjective Sleepiness using the Karolinska Sleepiness Scale (KSS)
Description
The Karolinska Sleepiness Scale (KSS) outcome prompts participants to rate how sleepy or alert they are feeling on a scale ranging from 1 to 9, where 1 = "very alert," 3 = "rather alert," 5 = "neither alert nor sleepy," 7 = "sleepy, but no difficulty remaining awake," and 9 = "very sleepy, fighting sleep, an effort to remain awake."
Time Frame
1 hour after intervention
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). Performance is assessed in percent correct and by measuring 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). Performance is assessed in percent correct and by measuring accuracy and Reaction Time (RT).
Time Frame
1 hour after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 (MoCA) score between 17 and 25
For the age-matched healthy controls, participants must not be diagnosed with mild cognitive impairment or Alzheimer's disease related dementias (MoCA score above 25).
Participants must score a 5 or less in the Pittsburgh Sleep Quality Index (PSQI)
Exclusion Criteria:
All participants must not be taking sleeping medication or oral melatonin
Presence of another brain disease that fully explains the dementia (extensive brain vascular disease, Parkinson'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 epilepsy
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
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
2265922
Citation
Akerstedt T, Gillberg M. Subjective and objective sleepiness in the active individual. Int J Neurosci. 1990 May;52(1-2):29-37. doi: 10.3109/00207459008994241.
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
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
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Rhythmic Light Therapy for Alzheimer's Disease Patients
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