Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children | Children ages 2 to <18 years of age will be enrolled |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Total sleep time | sleep minutes between lights off and lights on | Up to 10 days after consent |
| Wake after sleep onset | wake minutes between PSG-scored sleep onset and lights on | Up to 10 days after consent |
| Sleep efficiency | Total sleep time divided by sleep period or number of total min from lights off to lights on | Up to 10 days after consent |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Children ages 2 to < 18years
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eva C Diaz, MD | Contact | 5013646056 | ecdiazfuentes@uams.edu | |
| Tonja Nolen | Contact | 501-364-2853 | NolenTC@archildrens.org |
| Name | Affiliation | Role |
|---|---|---|
| Eva C Diaz, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Recruiting | Little Rock | Arkansas | 72202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27838682 | Background | 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. | |
| 2868172 | Background | Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10. |
Not provided
Not provided
study protocol, and consent, analytic code
upon publication of primary outcomes of interest
Researchers affiliated with recognized academic institutions who propose scientifically valid research questions.
Researchers will submit a data access request, including a study proposal, objectives, and intended use of the data.
Approval will be determined by a data-sharing committee or equivalent oversight body.
Not provided
Not provided
Not provided
Not provided
Not provided
Stool
| Arkansas Children's Nutrition Center | Recruiting | Little Rock | Arkansas | 72211 | United States |
|
| 31992999 | Background | 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. |
| 29403321 | Background | 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. |