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Recruiting NCT06787378

The Sweet Dreams Study - Accuracy of Sleep Trackers in Children

— Observational Sleep

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Sleep. Basic parameters: 2 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Primary outcome measures

  • Total sleep time [Time frame: Up to 10 days after consent]
  • Wake after sleep onset [Time frame: Up to 10 days after consent]
  • Sleep efficiency [Time frame: Up to 10 days after consent]

Eligibility criteria

Inclusion criteria

  • Age 2 to <18 years
  • All BMIs
  • Scheduled at PSDC for evaluation of obstructive sleep apnea, snoring, or noisy breathing during sleep.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 2 centers
  • Arkansas Children's Hospital — Little Rock
  • Arkansas Children's Nutrition Center — Little Rock

Publications

  • 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 27838682
  • Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10. PMID 2868172
  • 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. PMID 31992999
  • 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. PMID 29403321

Identifiers

NCT: NCT06787378 · 275668

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗