Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients
Phase 2 - The Use of Rhythmic Light Therapy to Entrain Gamma Oscillations and the Circadian System in Patients With Alzheimer's Disease
Icahn School of Medicine at Mount Sinai
120 participants
Aug 22, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- 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 Criteria5
- 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
Interventions
Narrowband blue light
40 hertz (Hz) flicker
Narrowband red light
Random flicker for placebo rhythmic effect
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT05016219