Using bright light therapy to treat excessive daytime sleepiness in Prader-Willi Syndrome
A Randomized, Double-Blind, Controlled Trial of Bright Light Therapy on All-Cause Excessive Daytime Sleepiness in Prader-Willi Syndrome
This study is testing if bright light therapy can help kids and teens with Prader-Willi Syndrome feel less sleepy during the day.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 6 Years to 88 Years |
| Sex | All |
| Sponsor | Maimonides Medical Center Academic / other |
| Locations | 1 site (Brooklyn, New York) |
| Trial ID | NCT05939453 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of bright light therapy in reducing excessive daytime sleepiness among patients diagnosed with Prader-Willi Syndrome (PWS). It is a prospective, placebo-controlled, open-label trial involving remote assessments over eight weeks, with participants undergoing weekly visits. The study measures changes in mood, behavior, body weight, and hyperphagia, utilizing tools like the Aberrant Behavior Checklist and actigraphy reports. Participants aged 6-18 with confirmed PWS will be screened for eligibility based on specific criteria.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 6-18 years with a confirmed diagnosis of Prader-Willi Syndrome and significant daytime sleepiness.
Not a fit: Patients with eye conditions that may be adversely affected by bright light or those with a history of psychosis or mania may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve the quality of life for patients with Prader-Willi Syndrome by alleviating excessive daytime sleepiness.
How similar studies have performed: While the use of light therapy is established in other conditions, this specific application for Prader-Willi Syndrome is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of PWS confirmed by genetic testing * Score of 12 or above on the Epworth Sleepiness Scale (ESS). Exclusion Criteria: * 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
Where this trial is running
Brooklyn, New York
- Maimonides Medical Center — Brooklyn, New York, United States (Recruiting)
Study contacts
- Principal investigator: Edward Yi, MD — Maimonides Health
- Study coordinator: Mayank Kumar, PhD
- Email: maykumar@maimo.org
- Phone: 718-283-8170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.