Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients
Study Phase: N/A
Recruitment Status: Recruiting
Start Date: August 22, 2023
End Date: July 31, 2027
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.
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
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Conditions:
- Cognitive Dysfunction