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NCT00691080 · ClinicalTrials.gov registry record
Understanding Sleep Problems in Children With Autism Spectrum Disorder
A clinical trial of Sleep Problems, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- 58
- Enrollment target
- 3
- Study locations
NCT00691080: Completed study of Sleep Problems, sponsored by Baylor College of Medicine.
NCT00691080 is a study of Sleep Problems that has completed, run by Baylor College of Medicine. The registered enrollment target is 58 participants, roughly in line with the 63-participant average among 7 other Sleep Problems trials with a reported enrollment target. The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00691080, a study of Sleep Problems, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- 58 participants
- Enrollment target
- 3
- Study locations
Study 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 role in regulating sleep-wake cycle. Children with ASD experience high rates of sleep disturbances that potentially contribute to problems with thinking and behavior. It is unclear if changes in MT production cause sleep problems in children with ASD. MT is frequently used to treat these sleep problems; however, it has not been well established whether MT is an effective treatment. Our hypotheses concerning MT is children with ASD and sleep problems will have a delayed sleep-wake cycle and/or decreased MT production. This study will compare children diagnosed with ASD to "healthy" control children with no ASD diagnosis. All subjects will be recruited from one of three sites: Baylor College of Medicine, Oregon Health \& Science University and Columbia University. The investigators will use a standardized questionnaire to determine whether the child has sleep problems. The investigators will measure MT levels in saliva in ASD children with sleep problems and in a group of control children without sleep problems. Total 24-hour MT production will be determined from urine samples in these same two groups.
Conditions Studied
Study Locations (3)
New York
- Columbia University - New York
Oregon
- Oregon Health & Sciences University - Portland
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2007-09 |
| Est. Completion | 2011-11 |
What the finished NCT00691080 record still lists
NCT00691080 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 58 participants, a relatively small participant target, roughly in line with the 63-participant average among 7 other Sleep Problems trials with a reported enrollment target.
The record links to 1 condition, with Sleep Problems appearing as the primary indexed condition, and to 0 interventions.
NCT00691080 reports a single indexed study location in New York, Oregon, Texas.
Frequently Asked Questions
What is clinical trial NCT00691080 about?
NCT00691080 is a clinical study titled "Understanding Sleep Problems in Children With Autism Spectrum Disorder". 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 role in regulating sleep-wake cycle. Children with ASD experience high rates of sleep disturbances t...
What is the current status of trial NCT00691080?
This trial is currently completed. The enrollment target is 58 participants. The study started on 2007-09. Estimated completion is 2011-11.
What conditions does trial NCT00691080 study?
This clinical trial studies the following conditions: Sleep Problems.
Who is sponsoring clinical trial NCT00691080?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00691080 being conducted?
This trial has 3 study locations across New York, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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