Behavior, Body Weight, Excessive Daytime Sleepiness, Hyperphagia, Mood, Prader-Willi Syndrome
Conditions
Keywords
Light Therapy, Aberrant Behavior Checklist, Clinical Global Impression- Improvement, Fitbit, Actigraphy reports, Epworth Sleepiness Scale, Hyperphagia Questionnaire (HQCT), Modified Overt Aggression Scale (MOAS)
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.
Interventions
OTHERSham Light
Sham treatment will be provided from a light box at a distance of at least 70cm but no greater than 90cm.
OTHERBright 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.
Sponsors
Maimonides Medical Center
Foundation for Prader-Willi Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 88 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Contacts
CONTACTMayank Kumar, PhD
CONTACTTheresa Jacob, MPH, PhD
PRINCIPAL_INVESTIGATOREdward Yi, MD
Maimonides Health
Outcome results
None listed