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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00795236
Other study ID # eIRB 4664
Secondary ID 2R01HD042125-06
Status Terminated
Phase N/A
First received
Last updated
Start date November 2009
Est. completion date June 2015

Study information

Verified date November 2019
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 13
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 20 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Oregon Health and Science University Portland Oregon

Sponsors (2)

Lead Sponsor Collaborator
Oregon Health and Science University Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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