Young Blind Child Melatonin Treatment Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alfred Lewy, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00688935
First received: May 30, 2008
Last updated: November 9, 2013
Last verified: November 2013
  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
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:
Responsible Party: Alfred Lewy, Senior Vice Chair and Professor, Psychiatry, Oregon Health and Science University
ClinicalTrials.gov 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:
melatonin
circadian rhythms
sleep
sleep disorders

Additional relevant MeSH terms:
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 16, 2014