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Melatonin Studies of Totally Blind Children

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Oregon Health and Science University.
Recruitment status was:  Recruiting
Information provided by:
Oregon Health and Science University Identifier:
First received: November 19, 2008
Last updated: July 15, 2011
Last verified: July 2011
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 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
Drug: Melatonin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Melatonin Studies in Young Blind Children and Adolescents

Resource links provided by NLM:

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: Approximately 1 year ]
  • To test for a proportional difference in circadian status (free-running versus entrained) between pre and post- pubertal males in blind boys and young men, a chi-square test of significance will be used for each age group. [ Time Frame: Approximately 1 year ]
  • To determine the efficacy of melatonin treatment in entraining blind free-running children and young adults, a binomial test will be used. [ Time Frame: Approximately 1 year ]

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
No Intervention: Observational
Observe to determine free-running versus entrained status.
Experimental: Melatonin
Subjects with free-running rhythms will take melatonin.
Drug: Melatonin
One 0.5 mg tablet of melatonin will be taken by subjects who are free-running and willing to enter the intervention phase of the study. These subjects will take melatonin until entrainment status is confirmed or throughout the duration of the study.

Detailed Description:
Subjects will be asked to collect saliva samples in their home hourly throughout the daytime, approximately every 2 weeks. 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. Subjects will be discontinued after their monitoring period is over or after an entrained status has been confirmed. While no specific time commitment is required, we hope most subjects will participant for 4 months - 2 years.

Ages Eligible for Study:   5 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00795236

United States, Oregon
Oregon Health and Science University Recruiting
3181 SW Sam Jackson Park Road, Oregon, United States, 97239
Contact: Amber Laurie    866-424-6060   
Sponsors and Collaborators
Oregon Health and Science University
Principal Investigator: Alfred Lewy, MD, PhD Oregon Health and Science University
  More Information

Responsible Party: Alfred Lewy, MD, PhD, Oregon Health and Science University Identifier: NCT00795236     History of Changes
Other Study ID Numbers: eIRB 4664
2R01HD042125-06 ( US NIH Grant/Contract Award Number )
Study First Received: November 19, 2008
Last Updated: July 15, 2011

Keywords provided by Oregon Health and Science University:

Additional relevant MeSH terms:
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Vision Disorders
Sensation Disorders
Eye Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants processed this record on May 23, 2017