Trials / Terminated
TerminatedNCT00688935
Young Blind Child Melatonin Treatment Study
Identification of Free-Running Rhythms in Blind Children
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Oregon Health and Science University · Academic / Other
- Sex
- All
- Age
- 1 Year – 20 Years
- Healthy volunteers
- Not accepted
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 primary sleep disorders.
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Melatonin | 0.1-3 mg, daily, up to 1 year (minimum duration of 6 weeks) |
Timeline
- Start date
- 2005-01-01
- Primary completion
- 2015-05-01
- Completion
- 2015-05-01
- First posted
- 2008-06-03
- Last updated
- 2019-11-27
- Results posted
- 2019-11-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00688935. Inclusion in this directory is not an endorsement.