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...
Date First Received: May 30, 2008
Last Updated: June 2, 2008
Verified by: Oregon Health and Science University, May 2008
Clinical Trial Phase: N/A | Start Date: January 2005
Overall Status: Active, not recruiting
Estimated Enrollment: 25
Brief Summary
Official Title: “Identification of Free-Running Rhythms in Blind Children”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Diagnostic, Non-Randomized, Single Blind (Subject), Uncontrolled, Single Group Assignment, Efficacy Study
Study Primary Completion Date: June 2008
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Dietary Supplement: Melatonin
- 0.1-3 mg, daily, up to 1 year (minimum duration of 6 weeks)
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- 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.
Outcome Measures for this Clinical Trial
Primary Measures
- 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
Safety Issue?: No
- Time Frame: every 2-4 weeks throughout the entire study
Secondary Measures
- Polysomnography (sleep assessment)
- Time Frame: 1 12-hour assessment any time during the study
Safety Issue?: No
- Time Frame: 1 12-hour assessment any time during the study
Criteria for Participation in this Clinical Trial
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).
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 1 Year
Maximum Age for this Clinical Trial: 20 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Oregon Health and Science University
Overall Clinical Trial Officials and Contacts
Alfred J Lewy, MD, PhD Principal Investigator Oregon Health and Science University
Related Publications
References
Palm L, Blennow G, Wetterberg L. Long-term melatonin treatment in blind children and young adults with circadian sleep-wake disturbances. Dev Med Child Neurol. 1997 May;39(5):319-25.
Sack RL, Lewy AJ, Blood ML, Keith LD, Nakagawa H. Circadian rhythm abnormalities in totally blind people: incidence and clinical significance. J Clin Endocrinol Metab. 1992 Jul;75(1):127-34.
Tzischinsky O, Skene D, Epstein R, Lavie P. Circadian rhythms in 6-sulphatoxymelatonin and nocturnal sleep in blind children. Chronobiol Int. 1991;8(3):168-75.
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00688935
Study ID Number: eIRB 0714
ClinicalTrials.gov Identifier: NCT00688935
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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