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Sponsored by: |
National Eye Institute (NEI) |
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Information provided by: | National Eye Institute (NEI) |
ClinicalTrials.gov Identifier: | NCT00686907 |
The primary two foci of this five-year study will be to assess inter-individual variability in the timing of the body clock of blind individuals, and to optimize the melatonin dosing regimen for synchronizing body clocks of blind individuals to the 24-hour day.
Condition | Intervention |
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Blindness |
Dietary Supplement: Melatonin |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Single Blind (Subject), Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Melatonin for Circadian Sleep Disorders in the Blind |
Estimated Enrollment: | 200 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | February 2012 |
Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Melatonin dosing regimen to determine the optimal dose and administration time to synchronize the circadian rhythms of blind individuals to the 24-hour day.
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Dietary Supplement: Melatonin
Dose range: 0.025 - 20 mg, daily, up to 5 years (based on each subject's circadian rhythms and response to the dose).
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The first part of the study is observational, in which the body clock rhythms of blind individuals are assessed for variability in patterns across subjects. The second part of the study involves a melatonin treatment (0.025-.5 mg). The dose for each subject will be determined by the previous, observational data collected on the specifics of their individual body clock. The purpose of the intervention is to find an optimized dosing regimen and administration time to synchronize the body clocks of blind individuals, that seem to operate independent of the 24-hour environmental light/dark cycle, to the 24-hour day.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jeannie Songer, B.A. | 503-418-4144 | songerj@ohsu.edu |
United States, Oregon | |
Sleep and Mood Disorders Lab, Oregon Health & Science University | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact: Jeannie Songer, B.A. 503-418-4144 songerj@ohsu.edu | |
Contact: Alfred J Lewy, MD, PhD 503-494-7746 lewy@ohsu.edu | |
Sub-Investigator: Jonathan S Emens, MD | |
Principal Investigator: Alfred J Lewy, MD, PhD |
Principal Investigator: | Alfred J Lewy, MD, PhD | Oregon Health and Science University |
Responsible Party: | Oregon Health & Science University ( Alfred J. Lewy, MD, PhD / Senior Vice Chairman, Department of Psychiatry ) |
Study ID Numbers: | eIRB 1029, 9R01 EY018312-09A1 |
Study First Received: | May 28, 2008 |
Last Updated: | May 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00686907 |
Health Authority: | United States: Food and Drug Administration |
melatonin, circadian rhythms, sleep |
Signs and Symptoms Sensation Disorders Vision 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 |