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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Melatonin for Circadian Sleep Disorders in the Blind|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2007|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Melatonin dosing regimen to determine the optimal dose and administration time to synchronize the circadian rhythms of blind individuals to the 24-hour day.
Dose range: 0.01 mg - 20 mg, daily, up to 5 years (based on each subject's circadian rhythms and response to the dose).
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.
|United States, Oregon|
|Sleep and Mood Disorders Lab, Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Alfred J Lewy, MD, PhD||Oregon Health and Science University|