Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients
Recruiting · NCT05016219 · Interventional (participants receive a specific treatment) · Lead sponsor: Icahn School of Medicine at Mount Sinai
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
2 locations listed across 1 US state.
- Light and Health Research Center - Menands, New York, United States
- Icahn School of Medicine at Mount Sinai - New York, New York, United States