Clinical Trial: Blind Adult Melatonin Treatment Study

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Melatonin for Circadian Sleep Disorders in the Blind

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: National Eye Institute (NEI)

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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 ]

Original Secondary Outcome: Same as current

Information By: National Eye Institute (NEI)

Dates:
Date Received: May 28, 2008
Date Started: March 2007
Date Completion: July 2013
Last Updated: October 23, 2012
Last Verified: October 2012