RecruitingNot ApplicableNCT05016219

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

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

Enrollment

120 participants

Start Date

Aug 22, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 55 Years

Inclusion Criteria3

  • 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 Criteria5

  • 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

Interventions

DEVICECircadian-Effective Light

Narrowband blue light

DEVICERhythmic Light

40 hertz (Hz) flicker

DEVICEPlacebo Light

Narrowband red light

DEVICEPlacebo Rhythmic Light

Random flicker for placebo rhythmic effect


Locations(2)

Light and Health Research Center

Menands, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

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NCT05016219


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