Understanding Sleep Problems in Children With Autism Spectrum Disorder

Completed

Conditions studied: Sleep Problems

In brief

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.

Key facts

Study ID

NCT00691080

Run by

Baylor College of Medicine

People needed

58

Starts

2007-09-01

Expected to finish

2011-11-01

Last updated by the study team

2016-01-13

Who can join

Age: 4 and older, up to 9. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Columbia University — New York, New York, United States
• Oregon Health & Sciences University — Portland, Oregon, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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