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

RecruitingNAAges 55 Years - anyAllIcahn School of Medicine at Mount Sinai
NCT05016219 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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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What it tests

  • Circadian-Effective Light
  • Rhythmic Light
  • Placebo Light
  • Placebo Rhythmic Light
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Where

2 sites
Light and Health Research Center
Menands, United States
Icahn School of Medicine at Mount Sinai
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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