Understanding Sleep Problems in Children With Autism Spectrum Disorder

NCT00691080 | Completed DMC

• 1 other identifier: 2003
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 3

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 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

Sleep Problems

Keywords

Melatonin; Sleep; Autism; ASD; Sleep problems in children with autism spectrum disorder

Outcome Measures

Primary Outcomes (1)

• Sleep Latency, as measured by actigraphy

  1 week

Secondary Outcomes (1)

• Total sleep time, as measured by actigraphy

  1 week

Study Arms (2)

ASD children

ASD children as defined by: 1. Age greater than or equal to 4 or less than or equal to 9 years 2. Diagnosis of Autism Spectrum Disorder; supported by ADOS and the ADI or SCQ (subjects). 3. No current use of psychoactive medications (e.g. fluoxetine, methylphenidate, risperidone, lithium, etc.) 4. No current or use within the last 1 month of beta-blockers or melatonin 5. No current use of sleep aids 6. No presence of untreated medical problems that could otherwise explain sleep problems (e.g. obstructive sleep apnea, gastroesophageal reflux disease - GERD) (6) No blindness.

"Healthy" control children

"Healthy" control children as defined by: 1. Age greater than or equal to 4 or less than or equal to 9 years 2. A SCQ score of less than 10 without parental or physician concern for another neurodevelopmental disorder will be used to define normal children. 3. No current use of psychoactive medications (e.g. fluoxetine, methylphenidate, risperidone, lithium, etc.) 4. No current or use within the last 1 month of beta-blockers or melatonin 5. No current use of sleep aids; 6. No presence of untreated medical problems that could otherwise explain sleep problems (e.g. obstructive sleep apnea, gastroesophageal reflux disease - GERD) (6) No blindness. (7) No current or past diagnosis of ADHD, depression, anxiety or with any other psychiatric conditions. (8) No sibling with a diagnosis of Autism Spectrum Disorder.

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with the diagnosis of ASD and that are not diagnosised with ASD (controls).

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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Autism Speaks: collaborator
• Oregon Health and Science University: collaborator
• Columbia University: collaborator
• The Emmes Company, LLC: collaborator
• Autism Treatment Network: collaborator

Study Sites (3)

Columbia University

New York, New York, 10032, United States

Location

Oregon Health & Sciences University

Portland, Oregon, 97239, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

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Biospecimen

Retention: NONE RETAINED

SAMPLE: Saliva What is the purpose of the sample collection? Determination of dim light melatonin onset (DMLO), as measured by salivary melatonin secretion. SAMPLE: Urine What is the purpose of the sample collection? Measurement of secreted 6-suplhatoxymaltonin, a metabolite of melatonin.

MeSH Terms

Conditions

Parasomnias; Autistic Disorder

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Study Officials

• Daniel G Glaze, M.D.

  Baylor College of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 3, 2008
• First Posted: June 5, 2008
• Study Start: September 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: November 1, 2011
• Last Updated: January 13, 2016

Record last verified: 2016-01

Locations

US (3)