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Recruiting Not applicable NCT05939453

Impact of Bright Light Therapy on Prader-Willi Syndrome

No applicable phase (e.g. observational)
Conditions: Prader-Willi Syndrome Excessive Daytime Sleepiness Hyperphagia Body Weight Mood Behavior

Sponsor: Maimonides Medical Center

trial.available_in: БГ
Overview
This is a placebo controlled clinical trial to assess the utility of light therapy as a sufficient treatment for excessive daytime sleepiness in patients with Prader-Willi Syndrome
Description
This is a prospective, placebo controlled, open label clinical trial that examines light therapy as a treatment for excessive daytime sleepiness in patients with Prader-Willi syndrome. Subjects are assessed for changes in mood, behavior, body weight, and hyperphagia during visits. All visits are conducted remotely. There are a total of 8 visits occurring over the course of 8 weeks. After the first visit, all study visits occur on a weekly basis. Individuals between the ages of 6-18 years old with diagnosis of PWS confirmed by genetic testing will be screened for enrolment by the study team.
Who can participate
Inclusion Criteria: * Diagnosis of PWS confirmed by genetic testing * Score of 12 or above on the Epworth Sleepiness Scale (ESS). Exclusion Criteria: * Subjects with an eye condition that could be negatively affected by bright light such as patients with a history of retinal damage or patients needing photosensitizing medications * A history of previous treatment with LT * Patients presenting with active psychosis or mania
Interventions
Sham Light
OTHER
Bright Light Therapy
OTHER
Locations 1
United States (1)
Maimonides Medical Center
Brooklyn , New York
Theresa Jacob, PhD, MPH
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
6 Years
Maximum age
88 Years
Healthy volunteers
No
Start date
01.10.2023
Completion date
01.12.2026
Registry ID
NCT05939453
Source
clinicaltrials.gov
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