Young Blind Child Melatonin Treatment Study

Blindness Clinical Trial

Official title:

Identification of Free-Running Rhythms in Blind Children

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00688935
• Other study ID #: eIRB 0714
• Secondary ID: n/a unfunded
• Status: Terminated
• Phase: N/A
• Start date: January 2005
• Est. completion date: May 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 20 Years

Eligibility

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).

Related Conditions & MeSH terms

• Blindness

Intervention

Biological:
• Melatonin
0.1-3 mg, daily, up to 1 year (minimum duration of 6 weeks)

Locations

Country	Name	City	State
United States	Sleep and Mood Disorders Lab, Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Palm L, Blennow G, Wetterberg L. Long-term melatonin treatment in blind children and young adults with circadian sleep-wake disturbances. Dev Med Child Neurol. 1997 May;39(5):319-25. — View Citation

Sack RL, Lewy AJ, Blood ML, Keith LD, Nakagawa H. Circadian rhythm abnormalities in totally blind people: incidence and clinical significance. J Clin Endocrinol Metab. 1992 Jul;75(1):127-34. — View Citation

Tzischinsky O, Skene D, Epstein R, Lavie P. Circadian rhythms in 6-sulphatoxymelatonin and nocturnal sleep in blind children. Chronobiol Int. 1991;8(3):168-75. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circadian Phase Marker, as Measured by the Melatonin Levels in Salivary, Plasma and/or Urine Serial Sampling.		every 2-4 weeks throughout the entire study
Secondary	Polysomnography (Sleep Assessment)		1 12-hour assessment any time during the study