Impact of Bright Light Therapy on Prader-Willi Syndrome

Study Overview
=================
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.

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

Conditions
-----------------
Prader-Willi Syndrome, Excessive Daytime Sleepiness, Hyperphagia, Body Weight, Mood, Behavior

Intervention / Treatment
-----------------
* Other: Sham Light
* Other: Bright Light Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham Light<br> | Other: Sham Light<br>* Sham treatment will be provided from a light box at a distance of at least 70cm but no greater than 90cm.<br>|
| Experimental: Light Therapy<br> | Other: Bright Light Therapy<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression- Improvement (CGI-I) | 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. | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aberrant Behavior Checklist | Consists of 2 subscales; irritability (15 items) and hyperactivity/noncompliance (16 items). | 8 Weeks | 
| Self-Injury Trauma scale | 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. | 8 Weeks | 
| Modified Overt Aggression Scale | 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 | 8 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Light Therapy, Aberrant Behavior Checklist, Clinical Global Impression- Improvement, Fitbit, Actigraphy reports, Epworth Sleepiness Scale, Hyperphagia Questionnaire (HQCT), Modified Overt Aggression Scale (MOAS)