Blind Adult Melatonin Treatment Study
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...
Brief Summary
Official Title: “Melatonin for Circadian Sleep Disorders in the Blind”
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.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
- Study Primary Completion Date: February 2012
Detailed Clinical Trial Description
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 (0.025-20 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.
Intervention(s) in this Clinical Trial
- 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).
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: A
- Melatonin dosing regimen to determine the optimal dose and administration time to synchronize the circadian rhythms of blind individuals to the 24-hour day.
Outcome Measures for this Clinical Trial
Primary Measures
- Circadian phase marker, as measured by the levels of melatonin in serial salivary and/or plasma samples
- Time Frame: Longitudinal study, up to 5 years
Safety Issue?: No
- Time Frame: Longitudinal study, up to 5 years
Secondary Measures
- Actigraph watch data as a means to see how melatonin treatment affects the subjects sleep/activity patterns.
- Time Frame: Longitudinal study, up to 5 years
Safety Issue?: No
- Time Frame: Longitudinal study, up to 5 years
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- blindness for at least one year, verified by an ophthalmologic exam
- ability to comply with the requirements of the experimental protocol
- competency to sign informed consent
Exclusion Criteria:
- abnormal heart, liver or kidney function
- a current Axis I psychiatric or substance abuse disorder according to the DSM-IV Manual
- external demands that limit the ability to maintain a regular schedule (e.g. night shift work)
- pregnancy
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 55 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: National Eye Institute (NEI) NIH
Overall Clinical Trial Officials and Contacts
Alfred J Lewy, MD, PhD Principal Investigator Oregon Health and Science University
Overall Contact: Andie Thompson 1-866-424-6060 sleeplab@ohsu.edu
Related Publications
References
Emens JS, Lewy AJ, Lefler BJ, Sack RL. Relative coordination to unknown "weak zeitgebers" in free-running blind individuals. J Biol Rhythms. 2005 Apr;20(2):159-67.
Lewy AJ, Emens J, Jackman A, Yuhas K. Circadian uses of melatonin in humans. Chronobiol Int. 2006;23(1-2):403-12. Review.
Lewy AJ. Melatonin as a marker and phase-resetter of circadian rhythms in humans. Adv Exp Med Biol. 1999;460:425-34. Review. No abstract available.
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00686907
Study ID Number: eIRB 1029
ClinicalTrials.gov Identifier: NCT00686907
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00686907
