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

January 12, 2016 updated by: Daniel Glaze, Baylor College of Medicine

Characterization of Endogenous Melatonin Profiles 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 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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Sciences University
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sleep Latency, as measured by actigraphy
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Total sleep time, as measured by actigraphy
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Collaborators

Columbia University
Oregon Health and Science University
Autism Speaks
The Emmes Company, LLC
Autism Treatment Network

Investigators

  • Study Director: Daniel G Glaze, M.D., Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

June 3, 2008

First Submitted That Met QC Criteria

June 4, 2008

First Posted (Estimate)

June 5, 2008

Study Record Updates

Last Update Posted (Estimate)

January 13, 2016

Last Update Submitted That Met QC Criteria

January 12, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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