Understanding Sleep Problems in Children With Autism Spectrum Disorder

Sleep Problems Clinical Trial

— REST  

Official title:

Characterization of Endogenous Melatonin Profiles in Children With Autism Spectrum Disorder.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00691080
• Other study ID #: 2003
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 3, 2008
• Last updated: January 12, 2016
• Start date: September 2007
• Est. completion date: November 2011

Study information

• Verified date: January 2016
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: November 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 9 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Child Development Disorders, Pervasive
• Dyssomnias
• Parasomnias
• Sleep Disorders
• Sleep Problems

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas
United States	Columbia University	New York	New York
United States	Oregon Health & Sciences University	Portland	Oregon

Sponsors (6)

Lead Sponsor	Collaborator
Baylor College of Medicine	Autism Speaks, Autism Treatment Network, Columbia University, Oregon Health and Science University, The EMMES Corporation

Country where clinical trial is conducted

United States, 

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* Note: There are 50 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Latency, as measured by actigraphy		1 week	No
Secondary	Total sleep time, as measured by actigraphy		1 week	No