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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
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have trouble sleeping, confirmed by tests.
Select...
I have mild memory loss or mild Alzheimer's with specific test scores.

Timeline

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

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

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
860 Previous Clinical Trials
524,356 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,672 Previous Clinical Trials
28,018,543 Total Patients Enrolled
Rutgers UniversityOTHER
113 Previous Clinical Trials
2,803,973 Total Patients Enrolled

Media Library

Lighting Intervention (Light Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04073628 — N/A
Mild Cognitive Impairment Research Study Groups: Active Lighting intervention, Control Lighting Intervention
Mild Cognitive Impairment Clinical Trial 2023: Lighting Intervention Highlights & Side Effects. Trial Name: NCT04073628 — N/A
Lighting Intervention (Light Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04073628 — N/A

Frequently Asked Questions

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

What are we aiming to learn from this clinical trial?

"The primary outcome of this study will be cognition, as measured by the Word Pairs Associates Task. Secondary outcomes include light exposure and sleep efficiency in MCI participants, as well as quality of life using the Dementia Quality of Life Instrument."

Answered by AI

Are people currently being accepted into this trial?

"The clinical trial is currently looking for participants. If you are interested, please visit clinicaltrials.gov for more information. This study was posted on June 14th, 2021 and updated on June 22nd, 2022."

Answered by AI

Who else is applying?

What state do they live in?
New York
Ohio
Pennsylvania
How old are they?
65+
18 - 65
What site did they apply to?
Icahn School of Medicine at Mount Sinai
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
2

What questions have other patients asked about this trial?

How long does screening take?
PatientReceived no prior treatments

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
The Long-term Impact of a Light Intervention on Sleep and Cognition in Mild Cognitive Impairment
Mariana Figueiro 2021. "The Long-term Impact of a Light Intervention on Sleep and Cognition in Mild Cognitive Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04073628.
All > Alzheimers Disease New York > Mild Cognitive Impairment
~7 spots leftby Jul 2024
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