Young Blind Child Melatonin Treatment Study
This trial is active, not recruiting.
|Sponsor||Oregon Health and Science University|
|Start date||January 2005|
|End date||May 2014|
|Trial size||25 participants|
|Trial identifier||NCT00688935, eIRB 0714, n/a unfunded|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
|Masking||single blind (subject)|
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
Polysomnography (sleep assessment)
time frame: 1 12-hour assessment any time during the study
Male or female participants from 1 year up to 20 years old.
Inclusion Criteria: - Age 1-20 years - Blindness for the past year (verified by an ophthalmologic exam), but otherwise in general good health. Exclusion Criteria: - Abnormal heart, lung, kidney, liver disease or a primary sleep disorder, - Significant clinical abnormalities (other than blindness), - Use of medications with known effects on melatonin metabolism (e.g. beta-adrenergic blocking drugs or tricyclic antidepressants).
|Official title||Identification of Free-Running Rhythms in Blind Children|
|Principal investigator||Alfred J Lewy, MD, PhD|
|Description||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.|
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