The Sweet Dreams Study - Accuracy of Sleep Trackers in Children
NCT ID: NCT06787378
Last Updated: 2025-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2025-03-01
2029-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Children
Children ages 2 to \<18 years of age will be enrolled
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* All BMIs
* Scheduled at PSDC for evaluation of obstructive sleep apnea, snoring, or noisy breathing during sleep.
Exclusion Criteria
* Neurological disorders (e.g., epilepsy, cerebral palsy, etc.)
* Autism spectrum disorder
* Attention deficit hyperactivity disorder
* Oppositional defiant disorder
* Chronic kidney disease
* Hormonal disease
* Autoimmune diseases
* Bleeding disorders
* Chronic infections (e.g., HIV, hepatitis B)
* Mental health disorders (e.g., depression, anxiety)
* Liver disease (e.g. hepatitis)
* Referral for evaluation of disorders other than obstructive sleep apnea, snoring, or noisy breathing during sleep.
* Pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest.
* Refusal to authorize study investigators to access data from the polysomnography test conducted at the Arkansas Children's Hospital PSDC.
2 Years
17 Years
ALL
Yes
Sponsors
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Arkansas Children's Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Eva C Diaz, MD
Role: PRINCIPAL_INVESTIGATOR
University of Arkansas
Locations
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Arkansas Children's Hospital
Little Rock, Arkansas, United States
Arkansas Children's Nutrition Center
Little Rock, Arkansas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Lu MJ, Zhong WH, Liu YX, Miao HZ, Li YC, Ji MH. Sample Size for Assessing Agreement between Two Methods of Measurement by Bland-Altman Method. Int J Biostat. 2016 Nov 1;12(2):/j/ijb.2016.12.issue-2/ijb-2015-0039/ijb-2015-0039.xml. doi: 10.1515/ijb-2015-0039.
Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
Smith C, Galland B, Taylor R, Meredith-Jones K. ActiGraph GT3X+ and Actical Wrist and Hip Worn Accelerometers for Sleep and Wake Indices in Young Children Using an Automated Algorithm: Validation With Polysomnography. Front Psychiatry. 2020 Jan 14;10:958. doi: 10.3389/fpsyt.2019.00958. eCollection 2019.
Quante M, Kaplan ER, Cailler M, Rueschman M, Wang R, Weng J, Taveras EM, Redline S. Actigraphy-based sleep estimation in adolescents and adults: a comparison with polysomnography using two scoring algorithms. Nat Sci Sleep. 2018 Jan 18;10:13-20. doi: 10.2147/NSS.S151085. eCollection 2018.
Other Identifiers
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275668
Identifier Type: -
Identifier Source: org_study_id
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