NCT06787378|Recruiting
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Sponsor study identifier
observational
300
1 country
2
Study Start
March 1, 2025
Actual (reported)Primary Completion
February 28, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 28, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 10, 2025
Actual (reported)January 22, 2025
Actual (reported)March 1, 2025
Actual (reported)February 28, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 28, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Children ages 2 to \<18 years of age will be enrolled
Children ages 2 to \< 18years
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72211, United States
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.
Stool
Eva C Diaz, MD
University of Arkansas
First Submitted
January 10, 2025
First Posted
January 22, 2025
Study Start
March 1, 2025
Actual (reported)Primary Completion
February 28, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The Effectiveness of a Proprietary of a Botanical Extract on Sleep Quality
Contact the study team to confirm eligibility.
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.
Study Completion
February 28, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 3, 2025
Record last verified: 2025-01
study protocol, and consent, analytic code
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