Clinical trial NCT06787378: The Sweet Dreams Study - Accuracy of Sleep Trackers in Children
Official title: The Sweet Dreams Study - Accuracy of Sleep Trackers in Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep
Keywords: sleep
accelerometer
polysomnography
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 300
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children ages 2 to \< 18years

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.

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.

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.

Primary outcomes:
measure: Total sleep time
timeFrame: Up to 10 days after consent
measure: Wake after sleep onset
timeFrame: Up to 10 days after consent
measure: Sleep efficiency
timeFrame: Up to 10 days after consent
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Eva C Diaz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
citation: 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.
citation: 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.