Status:
COMPLETED
Understanding Sleep Problems in Children With Autism Spectrum Disorder
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Autism Speaks
Oregon Health and Science University
Conditions:
Sleep Problems
Eligibility:
All Genders
4-9 years
Brief Summary
The investigators will examine whether sleep problems in children with autism spectrum disorder (ASD) are related to alterations in the production of melatonin (MT), a hormone that plays an important ...
Detailed Description
This is a proposal to study the relationship between melatonin (MT) and sleep problems in children with autism spectrum disorder (ASD), as part of the collaborative research structure of the Autism Tr...
Eligibility Criteria
Inclusion
- Diagnosis of Autism Spectrum Disorder; supported by ADOS and the ADI or SCQ (subjects).
- Age greater than or equal to 4 or less than or equal to 9 years;
- Parents have given informed consent.
- Parent/Caregiver fluent in written and spoken English.
- Controls only: A SCQ score of less than 10 without parental or physician concern for another neurodevelopmental disorder will be used to define normal children.
Exclusion
- Current use of psychoactive medications (e.g. fluoxetine, methylphenidate, risperidone, lithium, etc.)\*;
- Current or use within the last 1 month of beta-blockers or melatonin;
- Current use of sleep aids;
- Presence of untreated medical problems that could otherwise explain sleep problems (e.g. obstructive sleep apnea, gastroesophageal reflux disease - GERD);
- Blindness.
- Controls only: current or past diagnosis of ADHD, depression, anxiety or with any other psychiatric conditions. (7) Controls only: Sibling has a diagnosis of Autism Spectrum Disorder.
- Psychoactive medications can be discontinued but the parents must discuss medication discontinuation with their prescribing physician prior to reducing or stopping the medications.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00691080
Start Date
September 1 2007
End Date
November 1 2011
Last Update
January 13 2016
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Columbia University
New York, New York, United States, 10032
2
Oregon Health & Sciences University
Portland, Oregon, United States, 97239
3
Baylor College of Medicine
Houston, Texas, United States, 77030