Melatonin Studies of Totally Blind Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Oregon Health and Science University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00795236
First received: November 19, 2008
Last updated: July 15, 2011
Last verified: July 2011
  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 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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ 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
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.

  Eligibility

Ages Eligible for Study:   5 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
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: NCT00795236

Locations
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    sleeplab@ohsu.edu   
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Alfred Lewy, MD, PhD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Alfred Lewy, MD, PhD, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00795236     History of Changes
Other Study ID Numbers: eIRB 4664, 2R01HD042125-06
Study First Received: November 19, 2008
Last Updated: July 15, 2011
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by Oregon Health and Science University:
melatonin

Additional relevant MeSH terms:
Sleep Disorders
Parasomnias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
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 September 16, 2014