Young Blind Child Melatonin Treatment Study - Full Text View

Sponsored by:	Oregon Health and Science University
Information provided by:	Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00688935

Purpose

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
Blindness	Dietary Supplement: Melatonin

MedlinePlus related topics: Sleep Disorders

Drug Information available for: Melatonin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Single Blind (Subject), Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Identification of Free-Running Rhythms in Blind Children

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:	June 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: 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.	Dietary Supplement: 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.

Eligibility

Ages Eligible for Study:	1 Year to 20 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688935

Locations

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

Investigators

Principal Investigator:

Alfred J Lewy, MD, PhD

Oregon Health and Science University

More Information

OHSU Sleep and Mood Disorders Laboratory website This link exits the ClinicalTrials.gov site

Publications:

Palm L, Blennow G, Wetterberg L. Long-term melatonin treatment in blind children and young adults with circadian sleep-wake disturbances. Dev Med Child Neurol. 1997 May;39(5):319-25.

Sack RL, Lewy AJ, Blood ML, Keith LD, Nakagawa H. Circadian rhythm abnormalities in totally blind people: incidence and clinical significance. J Clin Endocrinol Metab. 1992 Jul;75(1):127-34.

Tzischinsky O, Skene D, Epstein R, Lavie P. Circadian rhythms in 6-sulphatoxymelatonin and nocturnal sleep in blind children. Chronobiol Int. 1991;8(3):168-75.

Responsible Party:	Oregon Health & Science University ( Alfred J. Lewy, MD, PhD / Senior Vice Chairman, Department of Psychiatry )
Study ID Numbers:	eIRB 0714, n/a unfunded
Study First Received:	May 30, 2008
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00688935
Health Authority:	United States: Food and Drug Administration

Keywords provided by Oregon Health and Science University:

melatonin
circadian rhythms
sleep
sleep disorders

Study placed in the following topic categories:

Signs and Symptoms
Sensation Disorders
Vision Disorders
Eye Diseases

Neurologic Manifestations
Sleep Disorders
Melatonin
Blindness

Additional relevant MeSH terms:

Antioxidants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases

Central Nervous System Depressants
Protective Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009