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Mild Cognitive ImpairmentSleepCognitive functionDevice

What this study is

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.

What's being tested

  • Circadian-Effective Light

    Intervention · DEVICE

    Narrowband blue light

  • Rhythmic Light

    Intervention · DEVICE

    40 hertz (Hz) flicker

  • Placebo Light

    Intervention · DEVICE

    Narrowband red light

  • Placebo Rhythmic Light

    Intervention · DEVICE

    Random flicker for placebo rhythmic effect

Study details

Official title
Phase 2 - The Use of Rhythmic Light Therapy to Entrain Gamma Oscillations and the Circadian System in Patients With Alzheimer's Disease
Sponsor
Icahn School of Medicine at Mount Sinai
Conditions
Mild Cognitive Impairment
Enrolling
120 people
Starts
2023-08-22
Est. completion
2027-07-31
Design
Double-blind, randomized, parallel groups
Record
View on ClinicalTrials.gov ↗