Young Blind Child Melatonin Treatment Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00688935
Recruitment Status : Unknown
Verified November 2013 by Alfred Lewy, Oregon Health and Science University.
Recruitment status was:  Active, not recruiting
First Posted : June 3, 2008
Last Update Posted : November 13, 2013
Information provided by (Responsible Party):
Alfred Lewy, 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.

Condition or disease Intervention/treatment Phase
Blindness Biological: Melatonin Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Identification of Free-Running Rhythms in Blind Children
Study Start Date : January 2005
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin
U.S. FDA Resources

Arm Intervention/treatment
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)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013

Keywords provided by Alfred Lewy, 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