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

Sponsor

Maimonides Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05939453

Collaborator

Foundation for Prader-Willi Research (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Prader-Willi Syndrome Excessive Daytime Sleepiness Hyperphagia Body Weight Mood Behavior	Other: Sham Light Other: Bright Light Therapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Controlled Trial of Bright Light Therapy on All-Cause Excessive Daytime Sleepiness in Prader-Willi Syndrome

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Sham Light	Other: Sham Light Sham treatment will be provided from a light box at a distance of at least 70cm but no greater than 90cm.
Experimental: Light Therapy	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.

Arm

Intervention/Treatment

Sham Comparator: Sham Light

Other: Sham Light

Sham treatment will be provided from a light box at a distance of at least 70cm but no greater than 90cm.

Experimental: Light Therapy

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.

Outcome Measures

Primary Outcome Measures

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

Aberrant Behavior Checklist [8 Weeks]
Consists of 2 subscales; irritability (15 items) and hyperactivity/noncompliance (16 items).
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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