Blindness
Conditions
Keywords
melatonin, circadian rhythms, sleep, sleep disorders
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALMelatonin
0.1-3 mg, daily, up to 1 year (minimum duration of 6 weeks)
Sponsors
Oregon Health and Science University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
1 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
* Age 1-20 years * Blindness for the past year (verified by an ophthalmologic exam), but otherwise in general good health.
Exclusion criteria
* Abnormal heart, lung, kidney, liver disease or a primary sleep disorder, * Significant clinical abnormalities (other than blindness), * Use of medications with known effects on melatonin metabolism (e.g. beta-adrenergic blocking drugs or tricyclic antidepressants).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Circadian Phase Marker, as Measured by the Melatonin Levels in Salivary, Plasma and/or Urine Serial Sampling. | every 2-4 weeks throughout the entire study |
Secondary
| Measure | Time frame |
|---|---|
| Polysomnography (Sleep Assessment) | 1 12-hour assessment any time during the study |
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 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.
Melatonin: 0.1-3 mg, daily, up to 1 year (minimum duration of 6 weeks) | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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
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
Polysomnography (Sleep Assessment)
Time frame: 1 12-hour assessment any time during the 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.