Melatonin Levels in Smith Magenis Syndrome (SMS)
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|ClinicalTrials.gov Identifier: NCT00691574|
Recruitment Status : Terminated (Unique provision in the American Recovery and Reinvestment Act prevented approval of second year no-cost-extension in which completion of analyses were planned.)
First Posted : June 5, 2008
Results First Posted : November 27, 2019
Last Update Posted : November 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chromosome Disorders||Dietary Supplement: Melatonin Device: Enviro-light artificial light box||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Melatonin Levels in Sleep-disordered Smith-Magenis Syndrome: a Pilot Study|
|Study Start Date :||September 1998|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||May 2009|
Active Comparator: 2
Subjects will sit in front of a fluorescent bright light box while completing plasma samples to test for melatonin suppression in blood. This will be completed by both the SMS patient group and the control group of elderly individuals.
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.
Other Name: bright light treatment
Subjects will take up to 3 mg of melatonin daily and will complete frequent (every 2-4 weeks) of saliva and/or plasma sampling to test for a change in the timing of the body clock in response to the melatonin.
Dietary Supplement: Melatonin
up to 3 mg, daily, for up to 1 year
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00691574
|United States, Oregon|
|Sleep and Mood Disorders Lab, Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Eilis Boudreau, MD||Oregon Health and Science University|