Blind Adult Melatonin Treatment Study

Status Active, not recruiting

Clinical Trial 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.

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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Blindness

Clinical Trial Details

NCT number	NCT00686907
Study type	Interventional
Source	National Eye Institute (NEI)
Contact
Status	Active, not recruiting
Phase	N/A
Start date	March 2007
Completion date	July 2013

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