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

Mount Sinai Health System

Status: Enrolling

Conditions: Mild Cognitive Impairment

Treatments: Device: Circadian-Effective Light; Device: Rhythmic Light; Device: Placebo Light; Device: Placebo Rhythmic Light

Study type: Interventional

Funder types: Other

Identifiers

NCT05016219

GCO 21-0378-02

Details and patient eligibility

About

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.

Full description

The tailored lighting intervention used to promote circadian entrainment will provide high circadian stimulation during the day produced by narrowband blue light peaking at 470 nanometers (nm). A comparison lighting intervention (i.e., placebo lighting), a narrowband red light peaking at 630 nm, will be used as a control. Both the red and the blue light devices will also provide either the 40 hertz (Hz) flicker (RL) or the random flicker (placebo RL). For the random flicker (placebo RL), the duty cycle will be delivered with a random interval determined by a Poisson process with an average interval of 40 hertz (Hz).

Enrollment: 120 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 4 patient groups, including a placebo group

Active Intervention plus Active Rhythm

Active Comparator group

Description:

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.

Treatment:

Device: Rhythmic Light

Device: Circadian-Effective Light

Active Light plus Placebo Rhythm

Active Comparator group

Description:

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.

Treatment:

Device: Placebo Rhythmic Light

Device: Circadian-Effective Light

Placebo Light plus Active Rhythm

Active Comparator group

Description:

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.

Treatment:

Device: Placebo Light

Device: Rhythmic Light

Placebo Light plus Placebo Rhythm

Placebo Comparator group

Description:

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.

Treatment:

Device: Placebo Rhythmic Light

Device: Placebo Light