Young Blind Child Melatonin Treatment Study

Not Applicable

Terminated

• Conditions: Blindness
• Interventions: Biological: Melatonin

• Registration Number: NCT00688935
• Lead Sponsor: Oregon Health and Science University

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 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.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2008-05-30
• Study First Submitted QC: 2008-06-02
• Study First Posted: 2008-06-03
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2019-11
• Results First Submitted: 2019-11-08
• Results First Submitted QC: 2019-11-08
• Last Update Submitted: 2019-11-08
• Results First Posted: 2019-11-27
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Melatonin	Melatonin	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.

Primary Outcome Measures

Name	Time	Method
Circadian Phase Marker, as Measured by the Melatonin Levels in Salivary, Plasma and/or Urine Serial Sampling.	every 2-4 weeks throughout the entire study

Secondary Outcome Measures

Name	Time	Method
Polysomnography (Sleep Assessment)	1 12-hour assessment any time during the study

Trial Locations

Locations (1)

Sleep and Mood Disorders Lab, Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States