Rhythmic Light Therapy for Alzheimer's Disease Patients
NCT ID: NCT05015478
Last Updated: 2024-12-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2022-01-10
2023-07-12
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Active Tailored Rhythmic Lighting then Inactive Placebo Rhythmic Lighting
1. hour intervention period where active lighting is experienced by participants. then 1 hour intervention period where an inactive, placebo lighting condition is experienced by participants.
2. sessions, 1 week apart
Tailored Rhythmic Lighting Intervention
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.
Inactive Placebo Rhythmic Lighting then Active Tailored Rhythmic Lighting
1. hour intervention period where an inactive, placebo lighting condition is experienced by participants. then 1 hour intervention period where active lighting is experienced by participants.
2. sessions, 1 week apart
Placebo Rhythmic Lighting Intervention
Placebo rhythmic light (RL) for a duration of 1 hour. In the placebo RL condition, the duty cycle will be delivered at randomly varying frequencies of 20 Hz and 50 Hz, specifically avoiding the frequency of 40 Hz. The placebo RL conditions will provide a 30 lux of red light on a vertical plane at the eye level.
Interventions
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Tailored Rhythmic Lighting Intervention
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.
Placebo Rhythmic Lighting Intervention
Placebo rhythmic light (RL) for a duration of 1 hour. In the placebo RL condition, the duty cycle will be delivered at randomly varying frequencies of 20 Hz and 50 Hz, specifically avoiding the frequency of 40 Hz. The placebo RL conditions will provide a 30 lux of red light on a vertical plane at the eye level.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
55 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Mariana Figueiro
Professor, Population Health Science and Policy
Principal Investigators
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Mariana Figueiro, PhD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Light and Health Research Center
Menands, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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GCO 21-0378-01
Identifier Type: -
Identifier Source: org_study_id