A Randomized, Double-Blind, Controlled Trial of Bright Light Therapy on All-Cause Excessive Daytime Sleepiness in Prader-Willi Syndrome
Maimonides Medical Center
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
Description
This is a prospective, placebo controlled, open label clinical trial that examines light therapy as a treatment for excessive daytime sleepiness in patients with Prader-Willi syndrome. Subjects are assessed for changes in mood, behavior, body weight, and hyperphagia during visits. All visits are conducted remotely. There are a total of 8 visits occurring over the course of 8 weeks. After the first visit, all study visits occur on a weekly basis. Individuals between the ages of 6-18 years old with diagnosis of PWS confirmed by genetic testing will be screened for enrolment by the study team.
Eligibility
- Age range
- 6–88 years
- Sex
- All
- Healthy volunteers
- No
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
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.
Location
- Maimonides Medical CenterBrooklyn, New York