Young Blind Child Melatonin Treatment Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Biological: Melatonin
0.1-3 mg, daily, up to 1 year (minimum duration of 6 weeks)
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Polysomnography (Sleep Assessment) [1 12-hour assessment any time during the study]
Eligibility Criteria
Criteria
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sleep and Mood Disorders Lab, Oregon Health & Science University | Portland | Oregon | United States | 97239 |
Sponsors and Collaborators
- Oregon Health and Science University
Investigators
- Principal Investigator: Alfred J Lewy, MD, PhD, Oregon Health and Science University
Study Documents (Full-Text)
None provided.More Information
Publications
- Palm L, Blennow G, Wetterberg L. Long-term melatonin treatment in blind children and young adults with circadian sleep-wake disturbances. Dev Med Child Neurol. 1997 May;39(5):319-25.
- Sack RL, Lewy AJ, Blood ML, Keith LD, Nakagawa H. Circadian rhythm abnormalities in totally blind people: incidence and clinical significance. J Clin Endocrinol Metab. 1992 Jul;75(1):127-34.
- Tzischinsky O, Skene D, Epstein R, Lavie P. Circadian rhythms in 6-sulphatoxymelatonin and nocturnal sleep in blind children. Chronobiol Int. 1991;8(3):168-75.
- eIRB 0714
- n/a unfunded
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Melatonin |
|---|---|
| Arm/Group Description | 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) |
| Period Title: Overall Study | |
| STARTED | 0 |
| COMPLETED | 0 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Melatonin |
|---|---|
| Arm/Group Description | 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) |
| Overall Participants | 0 |
| Age () [] | |
| <=18 years | |
| Between 18 and 65 years | |
| >=65 years | |
| Age () [] | |
| Sex: Female, Male () [] | |
| Female | |
| Male | |
| Region of Enrollment (participants) [] | |
Outcome Measures
| Title | Circadian Phase Marker, as Measured by the Melatonin Levels in Salivary, Plasma and/or Urine Serial Sampling. |
|---|---|
| Description | |
| Time Frame | every 2-4 weeks throughout the entire study |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Melatonin |
|---|---|
| Arm/Group Description | 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) |
| Measure Participants | 0 |
| Title | Polysomnography (Sleep Assessment) |
|---|---|
| Description | |
| Time Frame | 1 12-hour assessment any time during the study |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Melatonin |
|---|---|
| Arm/Group Description | 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) |
| Measure Participants | 0 |
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | 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. | |
| Arm/Group Title | Melatonin | |
| Arm/Group Description | 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) | |
All Cause Mortality |
||
| Melatonin | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Serious Adverse Events |
||
| Melatonin | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Other (Not Including Serious) Adverse Events |
||
| Melatonin | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | OHSU Integrity Department |
|---|---|
| Organization | Oregon Health and Science University |
| Phone | 1-877-733-8313 |
| irb@ohsu.edu |
- eIRB 0714
- n/a unfunded