Status:
TERMINATED
Young Blind Child Melatonin Treatment Study
Lead Sponsor:
Oregon Health and Science University
Conditions:
Blindness
Eligibility:
All Genders
1-20 years
Phase:
NA
Brief Summary
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 pr...
Detailed 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 complete...
Eligibility Criteria
Inclusion
- Age 1-20 years
- Blindness for the past year (verified by an ophthalmologic exam), but otherwise in general good health.
Exclusion
- 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).
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00688935
Start Date
January 1 2005
End Date
May 1 2015
Last Update
November 27 2019
Active Locations (1)
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1
Sleep and Mood Disorders Lab, Oregon Health & Science University
Portland, Oregon, United States, 97239