Impact of Bright Light Therapy on Prader-Willi Syndrome (PWS-LT)

Maimonides Medical Center

Status

Enrolling

Conditions

Behavior

Prader-Willi Syndrome

Mood

Body Weight

Hyperphagia

Excessive Daytime Sleepiness

Treatments

Other: Bright Light Therapy

Other: Sham Light

Study type

Interventional

Funder types

Other

Identifiers

NCT05939453

Study 2022-08-12-MMC

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

6 to 88 years old

Volunteers

No Healthy Volunteers

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