Maimonides Evening of Research
Fellow Winner
Shadman Khandaker, BA
Psychiatry
A Randomized, Double-Blind, Controlled Trial of Bright Light Therapy on All-Cause Excessive Daytime Sleepiness in Prader-Willi Syndrome
Background
Excessive Daytime Sleepiness (EDS) is common in patients with Prader-Willi Syndrome (PWS), a genetic disorder characterized by hyperphagia, muscular hypotonia, and cognitive/developmental disabilities. Light therapy (LT) is an established treatment for EDS in seasonal depression which improved circadian rhythms and promoted acute alertness in other populations. We hypothesized that LT would improve sleepiness, mood, and behavior in patients with PWS, with a primary objective of achieving significant reduction in Epworth Sleepiness Scale (ESS) scores.
Methods
This is an IRB-approved double-blind, randomized controlled trial with an open-label extension, for patients with PWS ages 6-88 years, having an ESS score ≥12. Power analysis gave sample size as 30 (15/group; 80% power, alpha 0.05). After two-week pre-randomization period to collect baseline sleep data, participants were randomized in a 1:1 ratio to receive either 30-minute twice daily LT sessions at 10,000 lux or sham (dim red-light) for three weeks (Phase 1). In Phase 2, all subjects were provided bright LT for three weeks. All procedures were conducted via a HIPAA-compliant video-based telehealth platform. Compliance required 28 logged LT sessions per phase. Actigraphy devices (Fitbit Luxe) monitored sleep stages, SpO2, heart rate variability, and other metrics to assess sleep quality. Weekly assessments by blinded raters included ESS, Hyperphagia Questionnaire (HCQT), Modified Overt Aggression Scale (MOAS), Clinical Global Impression scales (CGI), and Aberrant Behavior Checklist (ABC).
Results
At the end of Phase I, the LT group demonstrated a six-point reduction in ESS scores when compared to baseline (16.5±3.1 vs 10.3±3.9). ESS scores in the LT group were also lower than those in the sham group (10.3±3.9 vs 16.0±4.2). There was a reduction in HQCT scores, with a higher drop observed in the LT group (8.5±6.8 vs 17.0±4.2). At the end of the open-label extension phase, ESS scores and HQCT scores decreased in both groups. No serious adverse events were reported. Actigraphy recordings remain to be analyzed.
Conclusion
Preliminary results suggest LT effectively reduces EDS and positively impacts hyperphagia in PWS patients.
Implicatons
Given its accessibility, lack of need for medical supervision, and safety profile, LT may prove to be an excellent non-pharmacological means to address EDS in PWS.