Clinical Trial: Young Blind Child Melatonin Treatment Study

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Identification of Free-Running Rhythms in Blind Children

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 primary sleep disorders.

Detailed Summary: 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.
Sponsor: Oregon Health and Science University

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Polysomnography (sleep assessment) [ Time Frame: 1 12-hour assessment any time during the study ]

Original Secondary Outcome: Same as current

Information By: Oregon Health and Science University

Dates:
Date Received: May 30, 2008
Date Started: January 2005
Date Completion: May 2014
Last Updated: November 9, 2013
Last Verified: November 2013