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
|Condition or disease||Phase|
|Sleep Problems||Phase 2 Phase 3|
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|
|Actual Enrollment :||58 participants|
|Observational Model:||Case Control|
|Official Title:||Characterization of Endogenous Melatonin Profiles in Children With Autism Spectrum Disorder.|
|Study Start Date :||September 2007|
|Primary Completion Date :||September 2011|
|Study Completion Date :||November 2011|
ASD children as defined by:
(6) No blindness.
"Healthy" control children
"Healthy" control children as defined by:
(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.
- Sleep Latency, as measured by actigraphy [ Time Frame: 1 week ]
- Total sleep time, as measured by actigraphy [ Time Frame: 1 week ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00691080
|United States, New York|
|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|
|Study Director:||Daniel G Glaze, M.D.||Baylor College of Medicine|