Trials / Recruiting
RecruitingNCT05939453
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Maimonides Medical Center · Academic / Other
- Sex
- All
- Age
- 6 Years – 88 Years
- Healthy volunteers
- Not accepted
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
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Sham Light | Sham treatment will be provided from a light box at a distance of at least 70cm but no greater than 90cm. |
| OTHER | Bright 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. |
Timeline
- Start date
- 2023-10-01
- Primary completion
- 2026-01-01
- Completion
- 2026-06-01
- First posted
- 2023-07-11
- Last updated
- 2025-02-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05939453. Inclusion in this directory is not an endorsement.