Overview

This trial is active, not recruiting.

Condition blindness
Treatment melatonin
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (subject)
Primary purpose diagnostic
Arm
(Experimental)
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.
melatonin
0.1-3 mg, daily, up to 1 year (minimum duration of 6 weeks)

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Polysomnography (sleep assessment)
time frame: 1 12-hour assessment any time during the study

Eligibility Criteria

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).

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Oregon Health and Science University.