Rhythmic Light Therapy for Alzheimer's Disease Patients

Mild Cognitive Impairment Clinical Trial

Official title:

Phase 1 - The Use of Rhythmic Light Therapy to Entrain Gamma Oscillations and the Circadian System in Patients With Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05015478
• Other study ID #: GCO 21-0378-01
• Status: Completed
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: July 12, 2023

Study information

• Verified date: June 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 12, 2023
• Est. primary completion date: July 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Device:
• 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 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.

Locations

Country	Name	City	State
United States	Light and Health Research Center	Menands	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline
Primary	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.	1 hour after intervention
Secondary	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."	baseline
Secondary	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."	1 hour after intervention
Secondary	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).	baseline
Secondary	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).	1 hour after intervention