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Melatonin Studies of Totally Blind Children
This study is not yet open for participant recruitment.
Verified by Oregon Health and Science University, November 2008
Sponsored by: Oregon Health and Science University
Information provided by: Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00795236
  Purpose

The purpose of this study is to learn more about abnormal body rhythms in blind boys and girls that keep them from falling asleep at bed-time or cause them difficulty staying alert during the day. The investigators hope to adjust these rhythms to normal with daily melatonin capsules. The investigators hope to learn if there are any differences between the body rhythms of girls and boys. The investigators also want to investigate whether age or puberty have an effect on body rhythms.


Condition Intervention
Sleep Disorder
Blindness
Drug: Melatonin

MedlinePlus related topics: Sleep Disorders
Drug Information available for: Melatonin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Double Blind (Subject, Caregiver), Parallel Assignment
Official Title: Melatonin Studies in Young Blind Children and Adolescents

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

Primary Outcome Measures:
  • To test for a proportional gender difference in circadian status (free-running versus entrained) in blind children and in adolescents, a chi-square test of significance will be used for each age group. [ Time Frame: November 1, 2012 ] [ Designated as safety issue: No ]
  • We will utilize a binomial test to determine the efficacy of melatonin in entraining free-running blind children by examining the percentage of participants who entrain to 0.5 mg of melatonin. [ Time Frame: November 1, 2012 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: November 2009
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Melatonin: Experimental Drug: Melatonin
Subjects whose body clocks are found to not be synchronized (entrained) to the 24-hour day (those who have free-running rhythms), will take placebo or melatonin (0.5 mg-1.5 mg).
Observational: No Intervention

Detailed Description:

Subjects will be asked to collect saliva samples in their home hourly throughout the daytime, approximately every 2 weeks. Subjects whose body clocks are found to not be synchronized (entrained) to the 24-hour day (those who have free-running rhythms), will take placebo or melatonin (0.5 mg-1.5 mg). If this dosage of melatonin is successful, subjects will be observed less frequently (every 4 to 6 weeks) to ensure the melatonin continues to work. These subjects may be monitored for up to a year, after which they will be discontinued from the study. If subjects are found to be naturally entrained to the 24-hour day, they will be monitored longitudinally for changes. These subjects may also be monitored for up to one year. Subjects will be discontinued after their monitoring period is over or after an entrained status has been confirmed. All subjects will take placebo or melatonin during their participation and will not know at any time which they are taking. While no specific time commitment is required, we hope most subjects will participant for 4 months - 2 years.

  Eligibility

Ages Eligible for Study:   5 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Totally blind
  • Between 5-8 yrs or 17-20 yrs of age

Exclusion Criteria:

  • Pregnancy
  • Light perception
  • Low melatonin production
  • Taking melatonin
  • Co-morbid medical disorders (such as seizure disorders
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795236

Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Alfred Lewy, MD, PhD Oregon Health and Science University
  More Information

Responsible Party: Oregon Health and Science University ( Alfred Lewy, MD, PhD )
Study ID Numbers: PA07-070, 2R01HD042125-06
Study First Received: November 19, 2008
Last Updated: November 19, 2008
ClinicalTrials.gov Identifier: NCT00795236  
Health Authority: United States: Food and Drug Administration;   United States: Federal Government

Keywords provided by Oregon Health and Science University:
melatonin

Study placed in the following topic categories:
Signs and Symptoms
Sensation Disorders
Vision Disorders
Mental 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 14, 2009