NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients
| NCT ID | NCT05016219 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Mild Cognitive Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-08-22 |
| Primary Completion | 2026-07-31 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
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