Melatonin Studies of Totally Blind Children
This study is currently recruiting participants.
Verified July 2011 by Oregon Health and Science University
Sponsor:
Oregon Health and Science University
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
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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:
MedlinePlus related topics:
Sleep Disorders
Drug Information available for:
Melatonin
U.S. FDA Resources
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
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 Blindness Nervous System Diseases Neurologic Manifestations Signs and Symptoms Mental Disorders Vision Disorders Sensation Disorders Eye Diseases |
Melatonin Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 23, 2013