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Behavioural Intervention

Tailored Light Treatment for Dementia

Q: Is enrollment for this experiment being accepted at the present time?

<p>Affirmative. The details available on clinicaltrials.gov verifies that this trial, initially posted on February 14th 2023, is currently recruiting patients from two sites in need of 135 participants.</p>

Q: What is the total number of participants registered for this investigation?

<p>Correct. Clinicaltrials.gov shows that this clinical trial is still enrolling participants, following its initial posting on February 14th 2023 and latest update from April 20th 2023. A total of 135 patients are required at 2 sites for the experiment to be completed satisfactorily.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 14

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 14

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sleep Disturbance using the Pittsburgh Sleep Quality Index

Secondary outcome measures

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

861 Previous Clinical Trials

525,141 Total Patients Enrolled

Mariana Figueiro, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

9 Previous Clinical Trials

659 Total Patients Enrolled

Media Library

Active Lighting Intervention (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05837819 — N/A

Sleep Disorder Research Study Groups: Control Lighting Intervention, Active Lighting Intervention

Sleep Disorder 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this experiment being accepted at the present time?

"Affirmative. The details available on clinicaltrials.gov verifies that this trial, initially posted on February 14th 2023, is currently recruiting patients from two sites in need of 135 participants."

Answered by AI

What is the total number of participants registered for this investigation?

"Correct. Clinicaltrials.gov shows that this clinical trial is still enrolling participants, following its initial posting on February 14th 2023 and latest update from April 20th 2023. A total of 135 patients are required at 2 sites for the experiment to be completed satisfactorily."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Methodology Issues in a Tailored Light Treatment for Persons With Dementia - Aim 2

Mariana Figueiro 2023. "Methodology Issues in a Tailored Light Treatment for Persons With Dementia - Aim 2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05837819.

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