RecruitingNot ApplicableNCT05939453

Impact of Bright Light Therapy on Prader-Willi Syndrome

A Randomized, Double-Blind, Controlled Trial of Bright Light Therapy on All-Cause Excessive Daytime Sleepiness in Prader-Willi Syndrome


Sponsor

Maimonides Medical Center

Enrollment

50 participants

Start Date

Oct 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 YearsMax Age: 88 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether bright light therapy — a treatment commonly used for sleep disorders and seasonal depression — can reduce excessive daytime sleepiness in people with Prader-Willi Syndrome (PWS), a rare genetic condition that commonly causes extreme fatigue, overeating, and behavioral challenges. The study uses a placebo-controlled design conducted entirely through remote visits over 8 weeks. Children and adolescents aged 6 to 18 with a genetic diagnosis of PWS and significant daytime sleepiness (as measured by a standard scale) may be eligible, while those with eye conditions sensitive to bright light, prior light therapy treatment, or active psychosis or mania are excluded. Participation involves using a light therapy device at home for several weeks and attending weekly virtual visits with the study team. This summary was generated with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERSham Light

Sham treatment will be provided from a light box at a distance of at least 70cm but no greater than 90cm.

OTHERBright Light Therapy

Bright Light Therapy will be provided using light box with an artificial full spectrum lamp at a distance of at least 70cm but no greater than 90cm.


Locations(1)

Maimonides Medical Center

Brooklyn, New York, United States

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NCT05939453


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