Young Blind Child Melatonin Treatment Study
The primary goal of this study is to identify the presence of desynchronized circadian rhythms in 25 children by measuring melatonin secretion in serial blood or saliva samples, and to rule out any primary sleep disorders.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
|Official Title:||Identification of Free-Running Rhythms in Blind Children|
- Circadian phase marker, as measured by the melatonin levels in salivary, plasma and/or urine serial sampling. [ Time Frame: every 2-4 weeks throughout the entire study ] [ Designated as safety issue: No ]
- Polysomnography (sleep assessment) [ Time Frame: 1 12-hour assessment any time during the study ] [ Designated as safety issue: No ]
|Study Start Date:||January 2005|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Subjects may opt to enroll in this treatment sub-study involving melatonin treatment (0.1 - 3 mg, daily) for up to 1 year, with a minimum of 6 weeks. Throughout treatment, subjects will continue their saliva, plasma, and/or urine sampling to test for treatment efficacy.
0.1-3 mg, daily, up to 1 year (minimum duration of 6 weeks)
Subjects will complete 25-hours of hourly salivary, plasma sampling biweekly. Melatonin will be measured in urine, for children under the age of 3. Sleep and behavioral questionnaires will be completed by parents and/or teachers. This study involves an optional, 1-year melatonin treatment sub-study, in which the children will take 0.1 - 3mg daily. A second optional sub-study involves a study of the child's sleep through polysomnography, in order to identify possible sleep disorders.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688935
|United States, Oregon|
|Sleep and Mood Disorders Lab, Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Alfred J Lewy, MD, PhD||Oregon Health and Science University|