CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 52 enrolled / 52 target
Drug / intervention
Tailored Rhythmic Lighting Intervention +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05015478
NCT05015478N/ACompletedOn Track (1.0/mo)Completion was 33mo ago

Phase 1 - The Use of Rhythmic Light Therapy to Entrain Gamma Oscillations and the Circadian System in Patients With Alzheimer's Disease

Icahn School of Medicine at Mount Sinai·interventional·Posted Aug 20, 2021·Updated Jun 23, 2026

In Brief

A clinical study evaluating Tailored Rhythmic Lighting Intervention and Placebo Rhythmic Lighting Intervention for Mild Cognitive Impairment. Completed, enrolled 52 participants across 2 sites.

Detailed Summary

The investigator will investigate how light delivering 40 hertz (Hz) affects subjective sleep and cognition in a controlled laboratory study. A lab study will allow the collection of electroencephalogram (EEG) data, perform cognitive tests, and observe the response in those with mild cognitive impairment (MCI) compared to a healthy control group (HC). Participants will attend two study sessions over the course of two weeks. During both sessions, all participants will experience 10 minutes of a low-level light, followed by a data collection period which involves a sleepiness rating, an electroencephalogram (EEG) recording, and a computerized memory test. Participants will then experience either a RL or a placebo RL condition for one hour, after which there will be a second data collection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedAug 20, 2021
Enrollment StartJan 10, 2022
Primary CompletionSep 12, 2023
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 4.9 years ago

Arms & Interventions

Active Tailored Rhythmic Lighting then Inactive Placebo Rhythmic Lightingactive_comparator

1. hour intervention period where active lighting is experienced by participants. then 1 hour intervention period where an inactive, placebo lighting condition is experienced by participants. 2. sessions, 1 week apart

Device: Tailored Rhythmic Lighting Intervention
Inactive Placebo Rhythmic Lighting then Active Tailored Rhythmic Lightingplacebo_comparator

1. hour intervention period where an inactive, placebo lighting condition is experienced by participants. then 1 hour intervention period where active lighting is experienced by participants. 2. sessions, 1 week apart

Device: Placebo Rhythmic Lighting Intervention

Interventions

Tailored Rhythmic Lighting Interventiondevice

40 hertz (Hz) rhythmic lighting (RL) for a duration of 1 hour. The flicker frequency of the 40 Hz RL will be 40 Hz and the stimulation will be a square wave with a 50 % duty cycle (i.e., 12.5 milliseconds light- on and 12.5 milliseconds light-off). The RL will provide a 30 lux of red light on a vertical plane at the eye level.

Placebo Rhythmic Lighting Interventiondevice

Placebo rhythmic light (RL) for a duration of 1 hour. In the placebo RL condition, the duty cycle will be delivered at randomly varying frequencies of 20 Hz and 50 Hz, specifically avoiding the frequency of 40 Hz. The placebo RL conditions will provide a 30 lux of red light on a vertical plane at the eye level.