Impact of Bright Light Therapy on Prader-Willi Syndrome

Phase

N/A

Condition

Bulimia

Severe Short Stature

Hypogonadism

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

Sham Light

October 01, 2023

December 31, 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
Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.