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

30 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

Inclusion Criteria2

  • Diagnosis of PWS confirmed by genetic testing
  • Score of 12 or above on the Epworth Sleepiness Scale (ESS).

Exclusion Criteria3

  • 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

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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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