Status:
TERMINATED
Blind Elderly Melatonin Treatment Study
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Blindness
Eligibility:
All Genders
55+ years
Phase:
NA
Brief Summary
The primary focus of this five-year study will be to optimize the melatonin dosing regimen for synchronizing the body clocks of elderly blind individuals to the 24-hour day.
Detailed Description
The investigators intend to study as many as 26 subjects through up to four melatonin treatment regimens, all of which involve a dose step-down in which the melatonin dose will be reduced gradually to...
Eligibility Criteria
Inclusion
- Adults 55-100 years old
- Blindness for at least one year, verified by an ophthalmologic exam
- Ability to comply with the requirements of the experimental protocol
- No clinically significant abnormalities (other than blindness) on a general physical examination
- Subjects must be competent to sign informed consent
Exclusion
- Abnormal heart, liver or kidney function; a current Axis I psychiatric or substance abuse disorder according to the DSM-IV Manual
- A diagnosis of obstructive sleep apnea (apnea index \> 10) or nocturnal myoclonus (\> 10 associated arousals/hour)
- External demands that limit the ability to maintain a regular schedule, e.g., night shift work
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00692094
Start Date
August 1 2004
End Date
December 1 2008
Last Update
November 27 2019
Active Locations (1)
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1
Sleep and Mood Disorders Lab, Oregon Health & Science University
Portland, Oregon, United States, 97239