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

This study has been completed.
Sponsor:
Collaborators:
Autism Speaks
Oregon Health and Science University
Columbia University
The EMMES Corporation
Autism Treatment Network
Information provided by (Responsible Party):
Daniel Glaze, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00691080
First received: June 3, 2008
Last updated: January 12, 2016
Last verified: January 2016
  Purpose
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.

Condition Phase
Sleep Problems
Phase 2
Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Characterization of Endogenous Melatonin Profiles in Children With Autism Spectrum Disorder.

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Sleep Latency, as measured by actigraphy [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total sleep time, as measured by actigraphy [ Time Frame: 1 week ] [ Designated as safety issue: No ]

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.


Enrollment: 58
Study Start Date: September 2007
Study Completion Date: November 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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.


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.

  Eligibility

Ages Eligible for Study:   4 Years to 9 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children with the diagnosis of ASD and that are not diagnosised with ASD (controls).
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691080

Locations
United States, New York
Columbia University
New York, New York, United States, 10032
United States, Oregon
Oregon Health & Sciences University
Portland, Oregon, United States, 97239
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Autism Speaks
Oregon Health and Science University
Columbia University
The EMMES Corporation
Autism Treatment Network
Investigators
Study Director: Daniel G Glaze, M.D. Baylor College of Medicine
  More Information

Publications:

Responsible Party: Daniel Glaze, Principal Investigator, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00691080     History of Changes
Other Study ID Numbers: 2003 
Study First Received: June 3, 2008
Last Updated: January 12, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Melatonin
Sleep
Autism
ASD
Sleep problems in children with autism spectrum disorder

Additional relevant MeSH terms:
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Dyssomnias
Sleep Wake Disorders
Parasomnias
Neurodevelopmental Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants

ClinicalTrials.gov processed this record on December 08, 2016