Studying Childhood-onset Behavioral, Psychiatric, and Developmental Disorders
NCT01778504
Autism Spectrum Disorder, Autistic Disorder
Bethesda, Maryland, United States
View Trial DetailsNCT Number: NCT06787378
The study aims to evaluate the accuracy of sleep trackers in children aged 2 to less than 18 years. Children undergoing polysomnography, the gold standard for assessing sleep quality and duration, at Arkansas Children's Hospital may be eligible to participate. Participants will be asked to wear sleep trackers on the day of their sleep test. The data collected from the sleep trackers will be compared with the polysomnography results to determine the devices' accuracy.
Interested in participating?
Request Info2 year–17 year
All sexes
Observational
Arkansas Children's Hospital, Little Rock, Arkansas, United States
Participants will meet the research team at Arkansas Children's Hospital (ACH) two to three hours before their scheduled sleep test and are required to bring a stool sample from the child to the visit.
During the visit, the research team will gather information about the child's home environment and medical history, including parent marital status, parental education level, household income, and other factors. Questionnaires will also cover topics such as the child's growth and development, diet, physical activity, use of substances like tobacco and alcohol, and mood. Any questions that cause discomfort may be skipped by the child or their parent.
A brief physical exam will be conducted to measure the child's weight, height, blood pressure, and heart rate. Sleep trackers will then be programmed and placed, with two worn on the wrist and two around the waist. Instructions on how to remove and reattach the trackers will be provided to ensure proper use.
After completing the sleep test at ACH, the sleep trackers must be left in the sleep clinic. All four trackers must be returned, and parents will be asked to report if the trackers were removed at any point during the study.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Up to 10 days after consent
sleep minutes between lights off and lights on
Time frame: Up to 10 days after consent
wake minutes between PSG-scored sleep onset and lights on
Time frame: Up to 10 days after consent
Total sleep time divided by sleep period or number of total min from lights off to lights on
Contact information is provided by the study sponsor or research team.
Eva C Diaz, MD
CONTACT
Tonja Nolen
CONTACT
Arkansas Children's Hospital Research Institute
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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