The Sweet Dreams Study - Accuracy of Sleep Trackers in Children
1 other identifier
observational
300
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2025
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2025
CompletedFirst Posted
Study publicly available on registry
January 22, 2025
CompletedStudy Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2029
April 3, 2025
January 1, 2025
4 years
January 10, 2025
March 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (1)
Children
Children ages 2 to \<18 years of age will be enrolled
Eligibility Criteria
Children ages 2 to \< 18years
You may qualify if:
- Age 2 to \<18 years
- All BMIs
- Scheduled at PSDC for evaluation of obstructive sleep apnea, snoring, or noisy breathing during sleep.
You may not qualify if:
- Known diagnosis of sleep disorder
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72211, United States
Related Publications (4)
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.
PMID: 27838682BACKGROUNDBland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
PMID: 2868172BACKGROUNDSmith 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.
PMID: 31992999BACKGROUNDQuante 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.
PMID: 29403321BACKGROUND
Biospecimen
Stool
Study Officials
- PRINCIPAL INVESTIGATOR
Eva C Diaz, MD
University of Arkansas
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2025
First Posted
January 22, 2025
Study Start
March 1, 2025
Primary Completion (Estimated)
February 28, 2029
Study Completion (Estimated)
February 28, 2029
Last Updated
April 3, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- upon publication of primary outcomes of interest
- Access Criteria
- 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.
study protocol, and consent, analytic code