Blind Elderly Melatonin Treatment Study
Blindness
About this trial
This is an interventional treatment trial for Blindness focused on measuring melatonin, circadian rhythms, sleep
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Sleep and Mood Disorders Lab, Oregon Health & Science University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
1
2
3
4
Subjects will be given 0.5 mg at a time when melatonin should delay the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.
Subjects will be given 0.5 mg at a time when melatonin should advance the timing of their body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.
Subjects will be given a larger dose (up to 10 mg) at a time when the melatonin should advance the timing of the body clock. If the subject's body clock responds successfully to the dose, the dose will be reduced gradually until the lowest effective dose is found. If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.
Subjects will be given a larger dose (up to 20 mg) at a time when the melatonin should advance the timing of the body clock. If the subject successfully responds to the treatment, the dose will be reduced gradually until the lowest effective dose is determined (down to 0.025 mg). If the treatment does not work, the subject will be taken off treatment and later entered into a new treatment regimen.