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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05837819
Enrollment
135
Registered
2023-05-01
Start date
2023-02-14
Completion date
2025-07-31
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease, Sleep Disturbance

Brief summary

Aim 2 will investigate the effect of 3 different light exposure lengths on sleep, mood and agitation in persons with Alzheimer's disease. Participants will be randomly assigned to one of three conditions of light exposure: 1) 2-h morning light exposure; 2) 4-h morning light exposure; and 3) all day light exposure.

Interventions

Lighting intervention using high light levels designed to effect the circadian system

Lighting intervention using low light levels designed to not effect the circadian system

Sponsors

Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Extensive brain vascular disease, traumatic brain injury, multiple sclerosis, Parkinson's Disease * Obstructing cataracts * Severe macular degeneration * Use of sleep medication * Use of oral melatonin * untreated moderate to severe sleep apnea * Severe restless leg syndrome * Blindness

Design outcomes

Primary

MeasureTime frameDescription
Sleep Disturbance using the Pittsburgh Sleep Quality Indexup to week 14The PSQI is used to measure sleep quality and is composed of 19 items that generate 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction). Each subscale is scored 0 to 3. The sum of the 7 component scores yields a single global score with a range of 0 to 21. A higher score indicates higher sleep disturbance

Secondary

MeasureTime frameDescription
Sleep efficiency using actigraphyup to week 14Actigraphs will be worn continuously for 7 days during each assessment week. Changes in sleep efficiency will be measured using the actigraphy software. Sleep efficiency is a calculated as a ratio of the time spent in bed and the time spent sleeping.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMariana Figueiro, PhD

Icahn School of Medicine at Mount Sinai

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 2, 2026