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

What this Trial Is About

Researchers are evaluating the use of bright light therapy as a treatment for excessive daytime sleepiness in people with Prader-Willi Syndrome (PWS). This clinical trial is placebo-controlled and double-blinded, aiming to see if light therapy can improve sleepiness and affect mood, behavior, body weight, and hyperphagia in patients diagnosed with PWS confirmed by genetic testing. The study is sponsored by Maimonides Medical Center and involves participants aged 6 to 18 years old. Participants will receive either bright light therapy using a light box with an artificial full spectrum lamp or a sham light treatment from a light box at a similar distance. Treatments are administered remotely, with sessions occurring once a week over eight weeks, totaling eight visits. The study compares the effects of the actual bright light therapy against the sham treatment to assess its impact on daytime sleepiness and related symptoms. Throughout the trial, participants will be assessed remotely at weekly visits for changes in mood, behavior, body weight, hyperphagia, and overall improvement using clinical scales. The main outcome measured is the Clinical Global Impression-Improvement (CGI-I) scale after eight weeks. Secondary measures include behavior checklists and scales for self-injury and aggression. This study lasts eight weeks, with all visits conducted remotely to monitor safety and effectiveness.

Impact of Bright Light Therapy on Prader-Willi Syndrome