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

RECRUITINGN/ASponsored by Icahn School of Medicine at Mount Sinai
Actively Recruiting
PhaseN/A
SponsorIcahn School of Medicine at Mount Sinai
Started2023-08-22
Est. completion2026-07-31
Eligibility
Age55 Years+
Healthy vol.Accepted
Locations2 sites

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

Age: 55 Years+Healthy volunteers accepted
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

Conditions2

Alzheimer's DiseaseMild Cognitive Impairment

Locations2 sites

Light and Health Research Center
Menands, New York, 12204
Barbara Plitnick, BS518-242-4603Barbara.Plitnick@mountsinai.org
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Mariana Figueiro, PhD518-366-9306Mariana.Figueiro@mountsinai.org

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