We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Melatonin Studies of Totally Blind Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00795236
Recruitment Status : Unknown
Verified July 2011 by Oregon Health and Science University.
Recruitment status was:  Recruiting
First Posted : November 21, 2008
Last Update Posted : July 18, 2011
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Sleep Disorder Blindness Drug: Melatonin

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Melatonin Studies in Young Blind Children and Adolescents
Study Start Date : November 2009
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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    sleeplab@ohsu.edu   
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
ClinicalTrials.gov Identifier: NCT00795236     History of Changes
Other Study ID Numbers: eIRB 4664
2R01HD042125-06 ( U.S. NIH Grant/Contract )
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: July 18, 2011
Last Verified: July 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