Impact of Bright Light Therapy on Prader-Willi Syndrome

Last updated: February 24, 2025
Sponsor: Maimonides Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hypogonadism

Bulimia

Severe Short Stature

Treatment

Sham Light

Bright Light Therapy

Clinical Study ID

NCT05939453
Study 2022-08-12-MMC
  • Ages 6-88
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of PWS confirmed by genetic testing

  • Score of 12 or above on the Epworth Sleepiness Scale (ESS).

Exclusion

Exclusion Criteria:

  • Subjects with an eye condition that could be negatively affected by bright lightsuch as patients with a history of retinal damage or patients needingphotosensitizing medications

  • A history of previous treatment with LT

  • Patients presenting with active psychosis or mania

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Sham Light
Phase:
Study Start date:
October 01, 2023
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Maimonides Medical Center

    Brooklyn, New York 11219
    United States

    Active - Recruiting

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