An interventional study of Melatonin in Blindness, sponsored by Oregon Health and Science University. Terminated at 1 site in United States. Open to participants aged 1 Year to 20 Years. Per ClinicalTrials.gov, last updated 2019-11-27.
Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Diagnostic
The primary goal of this study is to identify the presence of desynchronized circadian rhythms in 25 children by measuring melatonin secretion in serial blood or saliva samples, and to rule out any primary sleep disorders.
Subjects will complete 25-hours of hourly salivary, plasma sampling biweekly. Melatonin will be measured in urine, for children under the age of 3. Sleep and behavioral questionnaires will be completed by parents and/or teachers. This study involves an optional, 1-year melatonin treatment sub-study, in which the children will take 0.1 - 3mg daily. A second optional sub-study involves a study of the child's sleep through polysomnography, in order to identify possible sleep disorders.
161 studies on the registry are indexed under Blindness; 33 are open to participants now.
This study's enrollment of 9 is below the median of 30 across 105 interventional studies indexed under Blindness.
Browse Blindness studies →Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects may opt to enroll in this treatment sub-study involving melatonin treatment (0.1 - 3 mg, daily) for up to 1 year, with a minimum of 6 weeks. Throughout treatment, subjects will continue their saliva, plasma, and/or urine sampling to test for treatment efficacy.
Biological: Melatonin
0.1-3 mg, daily, up to 1 year (minimum duration of 6 weeks)
Circadian Phase Marker, as Measured by the Melatonin Levels in Salivary, Plasma and/or Urine Serial Sampling.
Time frame: every 2-4 weeks throughout the entire study
Polysomnography (Sleep Assessment)
Time frame: 1 12-hour assessment any time during the study
| Milestone | Melatonin |
|---|---|
| Started | 0 |
| Completed | 0 |
| Not completed | 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 |
|---|---|---|---|
| Melatonin | — | — | — |
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 | Melatonin |
|---|---|
| <=18 years | — |
| Between 18 and 65 years | — |
| >=65 years | — |
| Age, Continuous | Melatonin |
|---|
| Sex: Female, Male | Melatonin |
|---|---|
| Female | — |
| Male | — |
| Region of Enrollment(participants) | Melatonin |
|---|
This study is terminated, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Oregon Health and Science University