Chromosome Disorders Clinical Trial
Official title:
Melatonin Levels in Sleep-disordered Smith-Magenis Syndrome: a Pilot Study
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.
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.
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