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Behavioural Intervention

Tailored Lighting for Alzheimer's Disease

N/A

Recruiting

Led By Mariana Figueiro, PhD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of mild to moderate Alzheimer's disease or related dementia

sleep disturbance as determined by a score ≥ 5 on the PSQI

Must not have

insulin-dependent diabetes

obstructing cataracts

Timeline

Screening 1 day

Treatment 26 weeks

Follow Up 0 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate whether 8 weeks of exposure to a tailored lighting intervention designed to increase circadian entrainment improves sleep, mood, inflammatory markers, and metabolic control in Alzheimer's patients, compared to a control group.

Who is the study for?

This trial is for individuals aged 60 or over with mild to moderate Alzheimer's disease or related dementia who have sleep disturbances. It excludes those with severe sleep apnea, restless leg syndrome, insulin-dependent diabetes, obstructing cataracts, or macular degeneration.

What is being tested?

The study tests if a Tailored Lighting Intervention (TLI) can improve circadian rhythms and treat metabolic issues in Alzheimer's patients. The intervention involves an 8-week exposure to special lighting compared to inactive lighting in a controlled crossover setting.

What are the potential side effects?

While the study focuses on light treatment which typically has minimal side effects, potential risks may include discomfort from the new lighting conditions or changes in sleep patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with mild to moderate Alzheimer's or similar dementia.

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You have trouble sleeping, which is confirmed by a score of 5 or higher on a sleep questionnaire.

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I am 60 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I use insulin for my diabetes.

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I have cataracts that block my vision.

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I have macular degeneration.

Timeline

Screening ~ 1 day1 visit

Treatment ~ 26 weeks6 visits

Follow Up ~ 0 days0 visits

Screening ~ 1 day

Treatment ~ 26 weeks

Follow Up ~0 days

This trial's timeline: 1 day for screening, 26 weeks for treatment, and 0 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Glucose tolerance

Change in depression

Change in sleep disturbance

Secondary study objectives

Light exposure using the Daysimeter

Sleep Efficiency using actigraphy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Aim 1: Placebo Intervention then ActiveExperimental Treatment1 Intervention

The placebo lighting intervention is designed to have no effect on the circadian system. The control intervention will be in place for 8 weeks. Following an 8 week washout period, the participants will see the active tailored lighting intervention for 8 weeks.

Group II: Aim 1: Active Intervention then PlaceboExperimental Treatment1 Intervention

Tailored Lighting intervention (TLI). The active TLI will provide high circadian stimulation during the day produced by light sources that provide moderate light levels of spectra that are tuned to the sensitivity of the circadian system. The active lighting intervention will be in place for 8 weeks. Following an 8 week washout period, the participants will see the placebo control intervention for 8 weeks.

0 / 6Eligibility criteria met