Melatonin Studies of Totally Blind Children

Sleep Disorder Clinical Trial

Official title:

Melatonin Studies in Young Blind Children and Adolescents

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00795236
• Other study ID #: eIRB 4664
• Secondary ID: 2R01HD042125-06
• Status: Terminated
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Blindness
• Sleep Disorder
• Sleep Wake Disorders

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