Melatonin Studies of Totally Blind Children
Status
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
The purpose of this study is to learn more about abnormal body rhythms in blind boys and girls that keep them from falling asleep at bed-time or cause them difficulty staying alert during the day. The investigators hope to learn if there are any differences between the body rhythms of girls and boys. The investigators also want to investigate whether age or puberty have an effect on body rhythms.
Full description
Subjects will be asked to collect saliva samples in their home hourly throughout the daytime, approximately every 2 weeks. Subjects may be monitored for up to a year, after which they will be discontinued from the study. If subjects are found to be naturally entrained to the 24-hour day, they will be monitored longitudinally for changes. Subjects will be discontinued after their monitoring period is over or after an entrained status has been confirmed. While no specific time commitment is required, we hope most subjects will participant for 4 months - 2 years.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Totally blind
- Between 5-8 yrs or 17-20 yrs of age
Exclusion criteria
- Pregnancy
- Light perception
- Low melatonin production
- Taking melatonin
- Co-morbid medical disorders (such as seizure disorders)
Trial design
Primary purpose
Allocation
Interventional model
Masking
13 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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