Impact of Bright Light Therapy on Prader-Willi Syndrome

Not Applicable

Recruiting

• Conditions: Prader-Willi Syndrome; Behavior; Hyperphagia; Body Weight; Excessive Daytime Sleepiness; Mood
• Interventions: Other: Sham Light; Other: Bright Light Therapy

• Registration Number: NCT05939453
• Lead Sponsor: Maimonides Medical Center

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

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.

Study Timeline

• Study First Submitted: 2022-12-12
• Study First Submitted QC: 2023-07-02
• Study First Posted: 2023-07-11
• Study Start: 2023-10-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-14
• Primary Completion: 2024-12
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Diagnosis of PWS confirmed by genetic testing
• Score of 12 or above on the Epworth Sleepiness Scale (ESS).

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham Light	Sham Light	-
Light Therapy	Bright Light Therapy	-

Primary Outcome Measures

Name	Time	Method
Clinical Global Impression- Improvement (CGI-I)	8 Weeks	A positive clinical response will be determined by a rating of 1 or 2 (Very much/Much improved) on the Clinical Global Impression- Improvement (CGI-I) scale at the end of the blinded trial.

Secondary Outcome Measures

Name	Time	Method
Self-Injury Trauma scale	8 Weeks	Scores of 5 or greater were found to be indicative of borderline personality disorder. Part 1 is ranking based on the number of wounds 1=one would (common in a mild self-injurious behavior but rare in a severe case) 2=two or four wounds (common) and 3=five or more wounds (rare). Injury severity is scored on a subjective basis with labels such as "mild" "moderate" and "severe" accompanied by descriptions of the observed state of the anatomy. Part 3 is the Estimate of Current Risk.
Modified Overt Aggression Scale	8 Weeks	Four-part behavior rating scale used to evaluate and document the "frequency and severity" of aggressive episodes.\[1\] The rating scale is made up of four categories; verbal aggression, aggression against objects, aggression against self, and aggression against others
Aberrant Behavior Checklist	8 Weeks	Consists of 2 subscales; irritability (15 items) and hyperactivity/noncompliance (16 items).

Trial Locations

Locations (1)

Maimonides Medical Center; 🇺🇸 Brooklyn, New York, United States