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.
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 find the lowest effective dose. The 4 treatment plans differ only in the start dose and the time of administration. Successfully treated subjects will enter a one-year intensive assessment of the safety and efficacy of melatonin treatment in which the subject will take the same dose for one year and complete biweekly assessments of efficacy and side-effects. The final phase of the study involves a placebo discontinuation, in which the subject's circadian rhythm will be returned to the baseline rhythm (this may take up to 6 months for some subjects).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
12
0.025 mg-0.5 mg, daily given at a time when it is expected to delay the timing of the body clock.
0.025 mg - 0.5 mg, daily, at a time when melatonin should advance the timing of their body clock.
0.025 mg - 10 mg, daily, at a time when melatonin should advance the timing of their body clock.
Sleep and Mood Disorders Lab, Oregon Health & Science University
Portland, Oregon, United States
Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples.
Time frame: biweekly throughout the entire study
Durability and Toxicity Side Effects Questionnaire
Time frame: 1 year
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0.025 mg - 20 mg, daily, at a time when the melatonin should advance the timing of the body clock.