Recruiting

Rhythmic Light Therapy

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT05016219

Conditions

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Circadian-Effective Light

Rhythmic Light

Placebo Light

Placebo Rhythmic Light

Study Details

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.

Conditions

Mild Cognitive Impairment

Study ID

NCT05016219

Start date

Aug 22, 2023

Status verified date

May, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active Intervention plus Active Rhythm

The device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time.

active comparator: Active Light plus Placebo Rhythm

The device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time.

active comparator: Placebo Light plus Active Rhythm

The device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time.

placebo comparator: Placebo Light plus Placebo Rhythm

The device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time.

Interventions

Circadian-Effective Light

Narrowband blue light

Rhythmic Light

40 hertz (Hz) flicker

Placebo Light

Narrowband red light

Placebo Rhythmic Light

Random flicker for placebo rhythmic effect

Primary outcome measure

  • Cognition using the Montreal Cognitive Assessment (MoCA) [ Time Frame: baseline ]
  • Cognition using the Montreal Cognitive Assessment (MoCA) [ Time Frame: at the end of week 9 ]
  • Cognition using the Montreal Cognitive Assessment (MoCA) [ Time Frame: at the end of week 14 ]

Central Contacts and Locations

Central contacts

Barbara Plitnick, BSN

518-242-4603barbara.plitnick@mountsinai.org

Mariana Figueiro, PhD

518-366-9306mariana.figueiro@mountsinai.org

Locations

Light and Health Research Center

Recruiting

Menands, New York, United States, 12204

Contacts

Barbara Plitnick, BS

518-242-4603Barbara.Plitnick@mountsinai.org

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Mariana Figueiro, PhD

518-366-9306Mariana.Figueiro@mountsinai.org

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • Light Treatment
  • Circadian Rhythms
  • Gamma Wave Entrainment
  • Rhythmic Light
  • Sleep
  • Cognition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-05-29.