Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Portland, Oregon 97239


Purpose:

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 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.


Criteria:

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


NCT ID:

NCT00686907


Primary Contact:

Principal Investigator
Alfred J Lewy, MD, PhD
Oregon Health and Science University


Backup Contact:

N/A


Location Contact:

Portland, Oregon 97239
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 16, 2018

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.