NCT00691574

Melatonin Levels in Smith Magenis Syndrome (SMS)

Melatonin Levels in Sleep-disordered Smith-Magenis Syndrome: a Pilot Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 3 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The goal of this pilot project is to determine whether melatonin levels are disordered in patients with Smith-Magenis Syndrome (SMS) and whether melatonin treatment can correct abnormal circadian rhythms in SMS patients. In addition, the study investigates the effects of bright light in an elderly control population that exhibits low melatonin secretion.

Detailed description

Participation involves 5 stages for SMS patients. First, Subjects will complete 4 sessions of 25-hour salivary or plasma sampling, with the last sampling occurring in front of a bright light box. Second, subjects will enroll in the melatonin treatment phase, involving a daily dose (up to 3 mg) for up to one year, with frequent (every 2-4 weeks) of 25-hour salivary or plasma sampling. During this stage, the subject and/or caregiver may also be asked to wear an activity wrist monitor, complete a daily sleep diary and behavioral questionnaires. Third, the subject may be asked to complete up to 3 25-hour sampling periods and take a melatonin pill on the same day to test how their body metabolizes the hormone, melatonin. The fourth stage is for subjects who are found to have an abnormal body rhythm. Subjects will complete a 25-hour plasma sampling period under bedrest to test for a hormone, Cortisol. The fifth stage is an optional 12-hour sleep analysis (polysomnography) to test for sleep disorders. Control participants will complete an abbreviated protocol of the 3 baseline 25-hour sampling periods and 1 involving bright light exposure.

Conditions

• Chromosome Disorders

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Melatonin	up to 3 mg, daily, for up to 1 year
DEVICE	Enviro-light artificial light box	Subjects will sit in front of an artificial, fluorescent light box (10,000 lux) while completing 25-hours of hourly plasma samples. The light lux level will be well below that identified as safe by the FDA.

Timeline

• Start date: 1998-09-01
• Primary completion: 2009-03-01
• Completion: 2009-05-01
• First posted: 2008-06-05
• Last updated: 2019-11-27
• Results posted: 2019-11-27

Locations

1 site across 1 country: United States