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Behavioural Intervention

Tailored Light Treatment for Dementia

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 Alzheimer's disease or related dementia with a Montreal Cognitive Assessment score <25
Sleep disturbance with a Pittsburgh Sleep Quality Index score ≥5
Must not have
Severe macular degeneration
Severe restless leg syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 14

Summary

This trial will test how light exposure affects sleep, mood & agitation in Alzheimer's patients, with 3 different lengths of exposure.

Who is the study for?
This trial is for individuals with Alzheimer's or related dementia, who have a Montreal Cognitive Assessment score below 25 and sleep disturbances indicated by a Pittsburgh Sleep Quality Index score of 5 or higher. It excludes those with major brain conditions, severe eye problems, use of sleep medication or melatonin, untreated sleep apnea, or severe restless leg syndrome.
What is being tested?
The study tests how different durations of morning light exposure affect the sleep quality, mood, and agitation levels in people with Alzheimer's disease. Participants will be randomly placed into groups receiving either 2 hours of morning light, 4 hours of morning light, or all-day light exposure.
What are the potential side effects?
Since this trial involves non-invasive lighting interventions to improve sleep patterns and behavior in dementia patients, there are minimal expected side effects. However specific individual sensitivities to changes in lighting cannot be entirely ruled out.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have Alzheimer's or similar dementia with a low cognitive score.
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I have trouble sleeping, scoring 5 or more on a sleep quality test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe vision loss due to macular degeneration.
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I have severe restless leg syndrome.
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I have moderate to severe sleep apnea that hasn't been treated.
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I do not have extensive brain vascular disease, traumatic brain injury, multiple sclerosis, or Parkinson's Disease.
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I have cataracts that block my vision.
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I am taking oral melatonin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sleep Disturbance using the Pittsburgh Sleep Quality Index
Secondary study objectives
Agitation using the Cohen-Mansfield Agitation Inventory (CMAI)
Cognitive status Using the Montreal Cognitive Assessment (MOCA)
Depression using the Cornell Scale for Depression in Dementia (CSDD)
+2 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active Lighting InterventionActive Control2 Interventions
Lighting intervention designed to effect the circadian system then will receive the control lighting intervention.
Group II: Control Lighting InterventionPlacebo Group1 Intervention
Lighting intervention using low light levels designed to not effect the circadian system

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
903 Previous Clinical Trials
541,632 Total Patients Enrolled
Mariana Figueiro, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
10 Previous Clinical Trials
740 Total Patients Enrolled

Media Library

Active Lighting Intervention (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05837819 — N/A
Alzheimer's Disease Research Study Groups: Control Lighting Intervention, Active Lighting Intervention
Alzheimer's Disease Clinical Trial 2023: Active Lighting Intervention Highlights & Side Effects. Trial Name: NCT05837819 — N/A
Active Lighting Intervention (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05837819 — N/A
~30 spots leftby Jun 2025
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