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Light Therapy

Light Therapy for Mild Cognitive Impairment

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

Subject has sleep disturbance indicated by a score >5 on the Pittsburgh Sleep Quality Index and sleep efficiency below 80% as indicated via actigraphy

Subject has diagnosis of amnestic mild cognitive impairment (MCI) or mild Alzheimer's disease (AD), as defined by a Montreal Cognitive Assessment (MoCA) score between 17 and 24 and those who fall between 0.5-4.0 and 4.5-9.0 in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) instrument

Timeline

Screening 3 weeks

Treatment Varies

Follow Up will be administered at baseline and the end of weeks 9,17, 25 and 37

Summary

This trial is studying the effects of long-term light exposure on sleep, memory, and other measures in people with mild memory problems or mild Alzheimer's disease.

Who is the study for?

This trial is for people living at home with mild cognitive impairment or early Alzheimer's, who have sleep issues and a caregiver willing to assist. They should score 17-24 on the MoCA test and 0.5-9.0 on the CDR-SOB scale.

What is being tested?

The study tests how a special lighting setup in participants' homes might affect their sleep quality and memory over time. It also looks at any changes in caregivers' sleep, cognition, depression, and life satisfaction.

What are the potential side effects?

Since this is a non-invasive light intervention, side effects may be minimal but could include discomfort from new lighting conditions or disruption of usual routines.

Eligibility Criteria

Inclusion Criteria

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

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I have trouble sleeping, confirmed by tests.

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I have mild memory loss or mild Alzheimer's with specific test scores.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ will be administered at baseline and the end of weeks 9,17, 25 and 37

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~will be administered at baseline and the end of weeks 9,17, 25 and 37

This trial's timeline: 3 weeks for screening, Varies for treatment, and will be administered at baseline and the end of weeks 9,17, 25 and 37 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Caregiver Burden using the Zarit Burden Interview (ZBI)

Cognition using Implicit Priming Task

Cognition using the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)

+6 more

Secondary study objectives

Cognition in the Caregiver using the Word Pairs Associates (WPA) Task

Cognition in the Caregiver using the Working Memory (WM) Task

Cognition using the Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) tool

+9 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active Lighting interventionActive Control1 Intervention

The active lighting intervention 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. Combining spectrum and light level, the intervention will allow us to: (1) use a light source that will stimulate the circadian system and (2) provide the participants with options as to how the light treatment will be delivered

Group II: Control Lighting InterventionPlacebo Group1 Intervention

The control lighting intervention will consist of low levels of a warm light source designed not to impact the circadian system.

0 / 2Eligibility criteria met