Melatonin Studies of Totally Blind Children

Oregon Health and Science University13 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sleep Disorder Blindness

Interventions

MelatoninDRUG

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.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Oregon Health and Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Approximately 1 year

Data from ClinicalTrials.gov

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