Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients

ID#: NCT05016219

Age: 55 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: July 01, 2023

End Date: December 31, 2026

Contact Information:
Barbara Plitnick, BSN
518-242-4603
Mariana Figueiro, PhD
518-366-9306
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 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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