NCT00795236

Melatonin Studies of Totally Blind Children

Melatonin Studies in Young Blind Children and Adolescents

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 5 Years – 20 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Sleep Disorder
• Blindness

Interventions

Type	Name	Description
DRUG	Melatonin	One 0.5 mg tablet of melatonin will be taken by subjects who are free-running and willing to enter the intervention phase of the study. These subjects will take melatonin until entrainment status is confirmed or throughout the duration of the study.

Timeline

• Start date: 2009-11-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2008-11-21
• Last updated: 2019-11-27
• Results posted: 2019-11-27

Locations

1 site across 1 country: United States