What this study is
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.
What's being tested
- Circadian-Effective Light
Intervention · DEVICE
Narrowband blue light
- Rhythmic Light
Intervention · DEVICE
40 hertz (Hz) flicker
- Placebo Light
Intervention · DEVICE
Narrowband red light
- Placebo Rhythmic Light
Intervention · DEVICE
Random flicker for placebo rhythmic effect
Study details
- Official title
- Phase 2 - The Use of Rhythmic Light Therapy to Entrain Gamma Oscillations and the Circadian System in Patients With Alzheimer's Disease
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Conditions
- Mild Cognitive Impairment
- Enrolling
- 120 people
- Starts
- 2023-08-22
- Est. completion
- 2027-07-31
- Design
- Double-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 55 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openLight and Health Research Center
Menands, New York, United States
- Barbara Plitnick, BS · Contact518-242-4603Barbara.Plitnick@mountsinai.org
RecruitingIcahn School of Medicine at Mount Sinai
New York, New York, United States
- Mariana Figueiro, PhD · Contact518-366-9306Mariana.Figueiro@mountsinai.org
Recruiting
Study team
Sponsor
Icahn School of Medicine at Mount Sinai
Study ID GCO 21-0378-02
Principal investigator
Mariana Figueiro, PhD
Icahn School of Medicine at Mount Sinai
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.