Status:
TERMINATED
Melatonin for Circadian Sleep Disorders in the Blind
Lead Sponsor:
Oregon Health and Science University
Conditions:
Insomnia
Blindness
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
This research project consists of a three part study with five embedded sub studies. The first study phase identifies "body rhythms" of sleepiness/wakefulness and of melatonin levels for each subject ...
Eligibility Criteria
Inclusion
- 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 (as determined by medical history and/or physical examination):
- abnormal heart, liver or kidney function
- a current Axis I psychiatric or substance abuse disorder according to the DSM-IV Manual
- possibly external demands that limit the ability to maintain a regular schedule (e.g., night shift work)
- sexually active female subjects of child-bearing potential will be asked to avoid pregnancy using accepted methods and will be notified that the effects of melatonin on a fetus are not known (we will ask subjects monthly if they are pregnant or trying to become pregnant)
- if a subject reports she is pregnant or is trying to become pregnant anytime during her study participation, any study medications (melatonin or placebo) will be immediately withdrawn and the subject will be excluded from the study
Exclusion
Key Trial Info
Start Date :
June 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00911053
Start Date
June 1 1997
End Date
June 1 2012
Last Update
November 27 2019
Active Locations (1)
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1
Oregon Health and Science University
Portland, Oregon, United States, 07239