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Sponsored by: |
Oregon Health and Science University |
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Information provided by: | Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT00795236 |
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 adjust these rhythms to normal with daily melatonin capsules. 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 |
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Sleep Disorder Blindness |
Drug: Melatonin |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Double Blind (Subject, Caregiver), Parallel Assignment |
Official Title: | Melatonin Studies in Young Blind Children and Adolescents |
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 |
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Melatonin: Experimental |
Drug: Melatonin
Subjects whose body clocks are found to not be synchronized (entrained) to the 24-hour day (those who have free-running rhythms), will take placebo or melatonin (0.5 mg-1.5 mg).
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Observational: No Intervention |
Subjects will be asked to collect saliva samples in their home hourly throughout the daytime, approximately every 2 weeks. Subjects whose body clocks are found to not be synchronized (entrained) to the 24-hour day (those who have free-running rhythms), will take placebo or melatonin (0.5 mg-1.5 mg). If this dosage of melatonin is successful, subjects will be observed less frequently (every 4 to 6 weeks) to ensure the melatonin continues to work. These 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. These subjects may also be monitored for up to one year. Subjects will be discontinued after their monitoring period is over or after an entrained status has been confirmed. All subjects will take placebo or melatonin during their participation and will not know at any time which they are taking. 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 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Oregon Health and Science University ( Alfred Lewy, MD, PhD ) |
Study ID Numbers: | PA07-070, 2R01HD042125-06 |
Study First Received: | November 19, 2008 |
Last Updated: | November 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00795236 |
Health Authority: | United States: Food and Drug Administration; United States: Federal Government |
melatonin |
Signs and Symptoms Sensation Disorders Vision Disorders Mental Disorders Eye Diseases |
Neurologic Manifestations Sleep Disorders Melatonin Blindness |
Antioxidants Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases |
Central Nervous System Depressants Protective Agents Central Nervous System Agents Pharmacologic Actions |