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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Sham treatment will be provided from a light box at a distance of at least 70cm but no greater than 90cm.
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.
Maimonides Medical Center
Brooklyn, New York, United States
RECRUITINGClinical 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.
Time frame: 8 Weeks
Aberrant Behavior Checklist
Consists of 2 subscales; irritability (15 items) and hyperactivity/noncompliance (16 items).
Time frame: 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.
Time frame: 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
Time frame: 8 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.