An interventional study of Melatonin and Regular Sleep Schedule in Insomnia, Blindness and Daytime Sleepiness, sponsored by Oregon Health and Science University. Terminated at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-11-27.
Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Treatment
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.
1,925 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 612 are open to participants now.
This study's enrollment of 59 is below the median of 72 across 1,689 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Oregon Health and Science University is the lead sponsor of 694 studies on the registry; 133 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 39 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria:
Exclusion criteria (as determined by medical history and/or physical examination):
Subjects will be administered melatonin.
Drug: Melatonin
Behavioral: Light
Behavioral: Regular Sleep Schedule
Optional longitudinal study, an extension of the first study stage, for subjects whose rhythms are not clearly free-running.
Melatonin will be administered under FDA IND #26,318, doses between 0.025 mg and 20 mg.
Subjects will maintain a regular sleep schedule of their choosing.
Subjects will be exposed to light.
Treatment Effects on Circadian Phase Will be Assessed During Each Trial by Measuring the Timing of Endogenous Melatonin Secretion.
Time frame: 1 year
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
| Milestone | Baseline | Melatonin | Light | Regular Sleep Schedule | Longitudinal Monitoring |
|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Baseline | — | — | — |
| Melatonin | — | — | — |
| Light | — | — | — |
| Regular Sleep Schedule | — | — | — |
| Longitudinal Monitoring | — | — | — |
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.
| Age, Categorical | Baseline | Melatonin | Light | Regular Sleep Schedule | Longitudinal Monitoring | Total |
|---|---|---|---|---|---|---|
| <=18 years | — | — | — | — | — | — |
| Between 18 and 65 years | — | — | — | — | — | — |
| >=65 years | — | — | — | — | — | — |
| Age, Continuous | Baseline | Melatonin | Light | Regular Sleep Schedule | Longitudinal Monitoring | Total |
|---|
| Sex: Female, Male | Baseline | Melatonin | Light | Regular Sleep Schedule | Longitudinal Monitoring | Total |
|---|---|---|---|---|---|---|
| Female | — | — | — | — | — | — |
| Male | — | — | — | — | — | — |
| Race and Ethnicity Not Collected | Baseline | Melatonin | Light | Regular Sleep Schedule | Longitudinal Monitoring | Total |
|---|
This study is terminated, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Melatonin
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