Melatonin Studies of Totally Blind Children

Not Applicable

Terminated

• Conditions: Sleep Disorder; Blindness
• Interventions: Drug: Melatonin

• Registration Number: NCT00795236
• Lead Sponsor: Oregon Health and Science University

Brief 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.

Study Timeline

• Study First Submitted: 2008-11-19
• Study First Submitted QC: 2008-11-19
• Study First Posted: 2008-11-21
• Study Start: 2009-11
• Results First Submitted: 2014-04-07
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-08
• Last Update Submitted: 2019-11-08
• Results First Posted: 2019-11-27
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Melatonin	Melatonin	Subjects with free-running rhythms will take melatonin.

Primary Outcome Measures

Name	Time	Method
To Test for a Proportional Gender Difference in Circadian Status (Free-running Versus Entrained) in Blind Children and in Adolescents, a Chi-square Test of Significance Will be Used for Each Age Group.	Approximately 1 year
To Test for a Proportional Difference in Circadian Status (Free-running Versus Entrained) Between Pre and Post- Pubertal Males in Blind Boys and Young Men, a Chi-square Test of Significance Will be Used for Each Age Group.	Approximately 1 year
To Determine the Efficacy of Melatonin Treatment in Entraining Blind Free-running Children and Young Adults, a Binomial Test Will be Used.	Approximately 1 year

Trial Locations

Locations (1)

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States