Melatonin for Circadian Sleep Disorders in the Blind
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Ocular |
| Therapuetic Areas: | Ophthalmology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | June 1997 |
| End Date: | March 2015 |
| Contact: | Andie Thompson |
| Email: | sleeplab@ohsu.edu |
| Phone: | 1-866-424-6060 |
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 (including sub-study 1). The second study phase identifies the
optimum dose and timing of melatonin for regulating each individual's 24-hour sleep/waking
cycle (including sub-study 2). The third study phase introduces a new independent variable,
light (including sub-studies 3 and 4). Sub-study 5 is an optional longitudinal study.
Sub-study 1 looks at how keeping a regular sleep schedule affects the body's natural rhythm.
Sub-study 2 looks at how individuals metabolize melatonin. Sub-study 3 tests how
individuals' endogenous melatonin production responds to bright outdoor light and Sub-study
4 tests a previous finding that artificial bright light exposed daily behind the knee can
regulate the body clock. Sub-study 5 is an optional longitudinal study, an extension of the
first study stage, for subjects whose rhythms are not clearly free-running.
first study phase identifies "body rhythms" of sleepiness/wakefulness and of melatonin
levels for each subject (including sub-study 1). The second study phase identifies the
optimum dose and timing of melatonin for regulating each individual's 24-hour sleep/waking
cycle (including sub-study 2). The third study phase introduces a new independent variable,
light (including sub-studies 3 and 4). Sub-study 5 is an optional longitudinal study.
Sub-study 1 looks at how keeping a regular sleep schedule affects the body's natural rhythm.
Sub-study 2 looks at how individuals metabolize melatonin. Sub-study 3 tests how
individuals' endogenous melatonin production responds to bright outdoor light and Sub-study
4 tests a previous finding that artificial bright light exposed daily behind the knee can
regulate the body clock. Sub-study 5 is an optional longitudinal study, an extension of the
first study stage, for subjects whose rhythms are not clearly free-running.
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
We found this trial at
1
site
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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