Clinical Trial: Melatonin Levels in Smith Magenis Syndrome (SMS)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Oregon Health and Science University

Current Primary Outcome: Circadian Phase Marker, as measured by the melatonin levels in serial salivary and/or plasma samples [ Time Frame: every 2-4 weeks throughout the entire study ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Polysomnography sleep disorder assessment [ Time Frame: 1 optional, 12-hour assessment towards the end of the study ]
  • Wrist actigraph activity levels as a secondary indicator of circadian phase [ Time Frame: every 2-4 weeks throughout the entire study along with every Circadian Phase Marker assessment ]


Original Secondary Outcome:

  • Polysomnography sleep disorder assessment [ Time Frame: 1 optional, 12-hour assessment towards the end of the study ]
  • Wrist actigraph activity levels as a secondary indicator of circadian phase [ Time Frame: daily throughout the entire study ]


Information By: Oregon Health and Science University

Dates:
Date Received: May 30, 2008
Date Started: September 1998
Date Completion:
Last Updated: November 9, 2013
Last Verified: November 2013