Blindness, Daytime Sleepiness, Insomnia
Conditions
Keywords
melatonin, sleep, blindness, blind individuals
Brief summary
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.
Interventions
DRUGMelatonin
Melatonin will be administered under FDA IND #26,318, doses between 0.025 mg and 20 mg.
BEHAVIORALRegular Sleep Schedule
Subjects will maintain a regular sleep schedule of their choosing.
BEHAVIORALLight
Subjects will be exposed to light.
Sponsors
Oregon Health and Science University
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment Effects on Circadian Phase Will be Assessed During Each Trial by Measuring the Timing of Endogenous Melatonin Secretion. | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Treatment Effects on Sleep and Alertness Will be Assessed by Daily Diaries and Daily Wrist Actigraphic Monitoring. Subjective Benefits Will be Assessed With Daily Ratings of Alertness and Vigor. | 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 |
|---|---|
| Baseline | 0 |
| Melatonin Subjects will be administered melatonin.
Melatonin: Melatonin will be administered under FDA IND #26,318, doses between 0.025 mg and 20 mg. | 0 |
| Light Light: Subjects will be exposed to light. | 0 |
| Regular Sleep Schedule Regular Sleep Schedule: Subjects will maintain a regular sleep schedule of their choosing. | 0 |
| Longitudinal Monitoring Optional longitudinal study, an extension of the first study stage, for subjects whose rhythms are not clearly free-running. | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Treatment Effects on Circadian Phase Will be Assessed During Each Trial by Measuring the Timing of Endogenous Melatonin Secretion.
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.
Secondary
Treatment Effects on Sleep and Alertness Will be Assessed by Daily Diaries and Daily Wrist Actigraphic Monitoring. Subjective Benefits Will be Assessed With Daily Ratings of Alertness and Vigor.
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.