Young Blind Child Melatonin Treatment Study

Oregon Health & Science University (OHSU)

Status: Terminated

Conditions: Blindness

Treatments: Biological: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT00688935

eIRB 0714

n/a unfunded

Details and patient eligibility

About

The primary goal of this study is to identify the presence of desynchronized circadian rhythms in 25 children by measuring melatonin secretion in serial blood or saliva samples, and to rule out any primary sleep disorders.

Full description

Subjects will complete 25-hours of hourly salivary, plasma sampling biweekly. Melatonin will be measured in urine, for children under the age of 3. Sleep and behavioral questionnaires will be completed by parents and/or teachers. This study involves an optional, 1-year melatonin treatment sub-study, in which the children will take 0.1 - 3mg daily. A second optional sub-study involves a study of the child's sleep through polysomnography, in order to identify possible sleep disorders.

Enrollment: 9 patients

Sex: All

Ages: 1 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 1-20 years
• Blindness for the past year (verified by an ophthalmologic exam), but otherwise in general good health.

Exclusion criteria

• Abnormal heart, lung, kidney, liver disease or a primary sleep disorder,
• Significant clinical abnormalities (other than blindness),
• Use of medications with known effects on melatonin metabolism (e.g. beta-adrenergic blocking drugs or tricyclic antidepressants).

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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9 participants in 1 patient group

Melatonin

Experimental group

Description:

Subjects may opt to enroll in this treatment sub-study involving melatonin treatment (0.1 - 3 mg, daily) for up to 1 year, with a minimum of 6 weeks. Throughout treatment, subjects will continue their saliva, plasma, and/or urine sampling to test for treatment efficacy.

Treatment:

Biological: Melatonin