Blind Adult Melatonin Treatment Study
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/21/2012 |
| Start Date: | March 2007 |
| End Date: | February 2012 |
| Contact: | Andie Thompson |
| Email: | sleeplab@ohsu.edu |
| Phone: | 1-866-424-6060 |
Melatonin for Circadian Sleep Disorders in the Blind
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.
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.
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
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