Melatonin Studies of Totally Blind Children
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| ClinicalTrials.gov Identifier: NCT00795236 |
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Recruitment Status :
Terminated
(Unique provision in the American Recovery and Reinvestment Act prevented approval of second year no-cost-extension in which completion of analyses were planned.)
First Posted : November 21, 2008
Results First Posted : November 27, 2019
Last Update Posted : November 27, 2019
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Sponsor:
Oregon Health and Science University
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Oregon Health and Science University
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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 | Phase |
|---|---|---|
| Sleep Disorder Blindness | Drug: Melatonin | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 13 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 |
| Actual Primary Completion Date : | June 2015 |
| Actual Study Completion Date : | June 2015 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Melatonin
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Observational
Observe to determine free-running versus entrained status.
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Experimental: Melatonin
Subjects with free-running rhythms will take melatonin.
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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. |
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 ]
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| Ages Eligible for Study: | 5 Years to 20 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| 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)
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
Locations
| United States, Oregon | |
| Oregon Health and Science University | |
| Portland, Oregon, United States, 97239 | |
Sponsors and Collaborators
Oregon Health and Science University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
| Principal Investigator: | Alfred Lewy, MD, PhD | Oregon Health and Science University |
| Responsible Party: | 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 |
| Results First Posted: | November 27, 2019 |
| Last Update Posted: | November 27, 2019 |
| Last Verified: | November 2019 |
Keywords provided by Oregon Health and Science University:
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melatonin |
Additional relevant MeSH terms:
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Sleep Wake Disorders Blindness Nervous System Diseases Neurologic Manifestations Signs and Symptoms Mental Disorders Vision Disorders Sensation Disorders |
Eye Diseases Melatonin Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Central Nervous System Depressants |