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Impact of Bright Light Therapy on Prader-Willi Syndrome

Impact of Bright Light Therapy on Prader-Willi Syndrome

Recruiting
6-18 years
All
Phase N/A

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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.

Eligibility

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

Study details
    Prader-Willi Syndrome
    Excessive Daytime Sleepiness
    Hyperphagia
    Body Weight
    Mood
    Behavior

NCT05939453

Maimonides Medical Center

27 January 2024

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