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NCT05939453NARecruiting

Impact of Bright Light Therapy on Prader-Willi Syndrome

Maimonides Medical Center

Start Date

10/1/2023

Completion Date

12/1/2026

Summary

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

Detailed 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.

Eligibility Criteria

Age Range: 6 years to 88 years

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

OTHER

Sham Light

OTHER

Bright Light Therapy

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Conditions

Prader-Willi SyndromeExcessive Daytime SleepinessHyperphagiaBody WeightMoodBehavior

Locations

Maimonides Medical Center

Brooklyn, New York 11219

United States