Bright Light Therapy for Prader-Willi Syndrome

This study is testing if Bright Light Therapy can help people with Prader-Willi Syndrome (PWS) who experience excessive daytime sleepiness. You might be able to join if you are between 6 and 88 years old, have a confirmed diagnosis of PWS, and score 12 or higher on the Epworth Sleepiness Scale (a measure of sleepiness). The study will compare Bright Light Therapy to a Sham Light (a light that looks similar but doesn't provide the same treatment). Researchers will look for improvements in your overall condition after 8 weeks. The study is currently unclear on its recruitment status and plans to enroll 50 participants.

Study design
This is an open-label, placebo-controlled study comparing Bright Light Therapy to a Sham Light. It aims to enroll 50 participants.
What's involved
You would have 8 remote visits over 8 weeks, with weekly visits after the first one. During these visits, changes in your mood, behavior, body weight, and hyperphagia (extreme hunger) will be assessed.
Compensation
Not stated in the trial record.
Follow-up
Your overall condition will be assessed at 8 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05939453

Impact of Bright Light Therapy on Prader-Willi Syndrome

Recruiting
NAAges 6–88InterventionalTreatment
Maimonides Medical Center
~50 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:Sham LightBright Light Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinical Global Impression- Improvement (CGI-I)
Measured over 8 Weeks
Prader-Willi Syndrome
Excessive Daytime Sleepiness
Hyperphagia
Body Weight
Mood
Behavior

NCT05939453

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Maimonides Medical Center

    Brooklyn, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Edward Yi, MD · PRINCIPAL_INVESTIGATOR · Maimonides Health

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Clinical Global Impression- Improvement (CGI-I)8 Weeks

    A positive clinical response will be determined by a rating of 1 or 2 (Very much/Much improved) on the Clinical Global Impression- Improvement (CGI-I) scale at the end of the blinded trial.