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Understanding Sleep Problems in Children With Autism Spectrum Disorder (REST)

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ClinicalTrials.gov Identifier: NCT00691080
Recruitment Status : Completed
First Posted : June 5, 2008
Last Update Posted : January 13, 2016
Sponsor:
Collaborators:
Autism Speaks
Oregon Health and Science University
Columbia University
The Emmes Company, LLC
Autism Treatment Network
Information provided by (Responsible Party):
Daniel Glaze, Baylor College of Medicine

Tracking Information
First Submitted Date June 3, 2008
First Posted Date June 5, 2008
Last Update Posted Date January 13, 2016
Study Start Date September 2007
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 12, 2016)
Sleep Latency, as measured by actigraphy [ Time Frame: 1 week ]
Original Primary Outcome Measures
 (submitted: June 4, 2008)
  • Sleep Latency, as measured by actigraphy [ Time Frame: 5 weeks ]
  • Improved Behavior, as measured by the Aberrant Behavior Checklist [ Time Frame: 5 Weeks ]
Change History
Current Secondary Outcome Measures
 (submitted: January 12, 2016)
Total sleep time, as measured by actigraphy [ Time Frame: 1 week ]
Original Secondary Outcome Measures
 (submitted: June 4, 2008)
  • Total sleep time, as measured by actigraphy [ Time Frame: 5 weeks ]
  • Decreased number of awakenings, as measured using actigraphy [ Time Frame: 5 weeks ]
  • Improved behavioral subdomain scores, as measured by the Aberrant Behavior Checklist [ Time Frame: 5 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Understanding Sleep Problems in Children With Autism Spectrum Disorder
Official Title Characterization of Endogenous Melatonin Profiles in Children With Autism Spectrum Disorder.
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.
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 Treatment Network (ATN). A major goal of the ATN is to conduct clinical research that will have a significant impact on the daily lives and functioning of individuals with ASD and to address immediate concerns of parents. Children with ASD experience high rates of sleep disturbance, which likely contribute to the severity of their daytime cognitive and behavioral dysfunction and to poorer quality of life for them and their families.

As a step toward addressing sleep problems in ASD, we propose to test the hypothesis that children with ASD and sleep problems will have a delay in MT onset and/or have decreased MT secretion over 24 hours compared to normal controls.

Primary endpoint: Characterize the endogenous MT profiles in children with ASD:

We predict that results from this study will reveal lower levels of metabolized MT in children with ASD when compared to normal children. In addition, we anticipate that children with ASD will have delayed MT onset or altered circadian phase.

Data from this study will provide important information concerning circadian rhythm dysregulation in ASD and will support the development of future studies using MT to modify and correct abnormal circadian rhythms.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:

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.

Sampling Method Non-Probability Sample
Study Population Children with the diagnosis of ASD and that are not diagnosised with ASD (controls).
Condition Sleep Problems
Intervention Not Provided
Study Groups/Cohorts
  • 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.

Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 12, 2016)
58
Original Estimated Enrollment
 (submitted: June 4, 2008)
120
Actual Study Completion Date November 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Diagnosis of Autism Spectrum Disorder; supported by ADOS and the ADI or SCQ (subjects).
  2. Age greater than or equal to 4 or less than or equal to 9 years;
  3. Parents have given informed consent.
  4. Parent/Caregiver fluent in written and spoken English.
  5. 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 Criteria:

  1. Current use of psychoactive medications (e.g. fluoxetine, methylphenidate, risperidone, lithium, etc.)*;
  2. Current or use within the last 1 month of beta-blockers or melatonin;
  3. Current use of sleep aids;
  4. Presence of untreated medical problems that could otherwise explain sleep problems (e.g. obstructive sleep apnea, gastroesophageal reflux disease - GERD);
  5. Blindness.
  6. 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 4 Years to 9 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00691080
Other Study ID Numbers 2003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Daniel Glaze, Baylor College of Medicine
Study Sponsor Baylor College of Medicine
Collaborators
  • Autism Speaks
  • Oregon Health and Science University
  • Columbia University
  • The Emmes Company, LLC
  • Autism Treatment Network
Investigators
Study Director: Daniel G Glaze, M.D. Baylor College of Medicine
PRS Account Baylor College of Medicine
Verification Date January 2016