Young Blind Child Melatonin Treatment Study
Primary Purpose
Blindness
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Melatonin
Sponsored by
About this trial
This is an interventional diagnostic trial for Blindness focused on measuring melatonin, circadian rhythms, sleep, sleep disorders
Eligibility 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).
Sites / Locations
- Sleep and Mood Disorders Lab, Oregon Health & Science University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Melatonin
Arm 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.
Outcomes
Primary Outcome Measures
Circadian Phase Marker, as Measured by the Melatonin Levels in Salivary, Plasma and/or Urine Serial Sampling.
Secondary Outcome Measures
Polysomnography (Sleep Assessment)
Full Information
NCT ID
NCT00688935
First Posted
May 30, 2008
Last Updated
November 8, 2019
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT00688935
Brief Title
Young Blind Child Melatonin Treatment Study
Official Title
Identification of Free-Running Rhythms in Blind Children
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
Unique provision in the American Recovery and Reinvestment Act prevented approval of second year no-cost-extension in which completion of analyses were planned.
Study Start Date
January 2005 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Health and Science University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blindness
Keywords
melatonin, circadian rhythms, sleep, sleep disorders
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Melatonin
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
Melatonin
Intervention Description
0.1-3 mg, daily, up to 1 year (minimum duration of 6 weeks)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Polysomnography (Sleep Assessment)
Time Frame
1 12-hour assessment any time during the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfred J Lewy, MD, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep and Mood Disorders Lab, Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
9236698
Citation
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. doi: 10.1111/j.1469-8749.1997.tb07438.x.
Results Reference
background
PubMed Identifier
1619000
Citation
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. doi: 10.1210/jcem.75.1.1619000.
Results Reference
background
PubMed Identifier
1794154
Citation
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. doi: 10.3109/07420529109063923.
Results Reference
background
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Young Blind Child Melatonin Treatment Study
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