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Recruiting NCT05939453
NCT05939453 Impact of Bright Light Therapy on Prader-Willi Syndrome
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Plain-language summary for patients
| NCT ID | NCT05939453 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maimonides Medical Center |
| Condition | Prader-Willi Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2026-06 |
Trial Parameters
Condition Prader-Willi Syndrome
Sponsor Maimonides Medical Center
Study Type INTERVENTIONAL
Phase N/A
Enrollment 50
Sex ALL
Min Age 6 Years
Max Age 88 Years
Start Date 2023-10-01
Completion 2026-06
All Conditions
Interventions
Sham LightBright Light Therapy
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Brief 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 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
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