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Young Blind Child Melatonin Treatment Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2013 by Oregon Health and Science University.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Alfred Lewy, Oregon Health and Science University Identifier:
First received: May 30, 2008
Last updated: November 9, 2013
Last verified: November 2013
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.

Condition Intervention
Biological: Melatonin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Identification of Free-Running Rhythms in Blind Children

Resource links provided by NLM:

Further study details as provided by Oregon Health and Science University:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Polysomnography (sleep assessment) [ Time Frame: 1 12-hour assessment any time during the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: January 2005
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: Melatonin
0.1-3 mg, daily, up to 1 year (minimum duration of 6 weeks)

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.

Ages Eligible for Study:   1 Year to 20 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations
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Please refer to this study by its identifier: NCT00688935

United States, Oregon
Sleep and Mood Disorders Lab, Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Principal Investigator: Alfred J Lewy, MD, PhD Oregon Health and Science University
  More Information

Additional Information:
Responsible Party: Alfred Lewy, Senior Vice Chair and Professor, Psychiatry, Oregon Health and Science University Identifier: NCT00688935     History of Changes
Other Study ID Numbers: eIRB 0714  n/a unfunded 
Study First Received: May 30, 2008
Last Updated: November 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Oregon Health and Science University:
circadian rhythms
sleep disorders

Additional relevant MeSH terms:
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants processed this record on October 21, 2016