Phase 1 Treatment of the Circadian Sleep Disturbance in Smith-Magenis Syndrome

This study examines the effect of bright light or melatonin treatment on sleep in children with Smith-Magenis syndrome (SMS). Children with SMS have a disrupted sleep cycle involving early waking, frequent daytime napping and frequent nighttime awakenings. Melatonin is a hormone normally produced at night in healthy people. People with SMS produce high levels of melatonin during the daytime and very low levels at night. This may affect their behavior, mood, attention span, and sleep patterns.

Two different treatment approaches will be used alone and in combination:

  • Bright light (BL) therapy administered during the daytime hours.
  • Administration of a delayed time-release melatonin tablet (dTR-melatonin) preparation taken at bedtime. The melatonin tablet was developed by the Pharmacy Development Services at NIH and approved by the FDA for use in this treatment study.

To get started:

  • Navigate through the menu on your left to learn more about the study.
  • Log In the application and fill out questionnaires.

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