Blindness
Conditions
Keywords
melatonin, circadian rhythms, sleep
Brief summary
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.
Detailed description
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).
Interventions
BIOLOGICALMelatonin
0.025 mg-0.5 mg, daily given at a time when it is expected to delay the timing of the body clock.
Sponsors
National Institute on Aging (NIA)
Oregon Health and Science University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples. | biweekly throughout the entire study |
Secondary
| Measure | Time frame |
|---|---|
| Durability and Toxicity Side Effects Questionnaire | 1 year |
Countries
United States
Participant flow
Pre-assignment details
The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
Participants by arm
| Arm | Count |
|---|---|
| Melatonin: 0.025 Mg-0.5 mg (Delay Timing) 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.
Melatonin: 0.025 mg-0.5 mg, daily given at a time when it is expected to delay the timing of the body clock. | 0 |
| Melatonin: 0.025 mg - 0.5 mg (Advance Timing) 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.
Melatonin: 0.025 mg - 0.5 mg, daily, at a time when melatonin should advance the timing of their body clock. | 0 |
| Melatonin: 0.025 mg - 10 mg (Advance Timing) 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.
Melatonin: 0.025 mg - 10 mg, daily, at a time when melatonin should advance the timing of their body clock. | 0 |
| Melatonin: 0.025 mg - 20 mg (Advance Timing) 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.
Melatonin: 0.025 mg - 20 mg, daily, at a time when the melatonin should advance the timing of the body clock. | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Circadian Phase Marker, as Measured by the Melatonin Levels in Serial Salivary and/or Plasma Samples.
Time frame: biweekly throughout the entire study
Population: The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
Secondary
Durability and Toxicity Side Effects Questionnaire
Time frame: 1 year
Population: The PI has retired from the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.