The Sweet Dreams Study - Accuracy of Sleep Trackers in Children

Last updated: March 31, 2025
Sponsor: Arkansas Children's Hospital Research Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06787378
275668
  • Ages 2-17
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 2 to <18 years

  • All BMIs

  • Scheduled at PSDC for evaluation of obstructive sleep apnea, snoring, or noisybreathing during sleep.

Exclusion

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, ornoisy breathing during sleep.

  • Pre-existing medical conditions or medications as determined by the investigators toaffect the outcomes of interest.

  • Refusal to authorize study investigators to access data from the polysomnographytest conducted at the Arkansas Children's Hospital PSDC.

Study Design

Total Participants: 300
Study Start date:
March 01, 2025
Estimated Completion Date:
February 28, 2029

Study 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.

Connect with a study center

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202
    United States

    Active - Recruiting

  • Arkansas Children's Nutrition Center

    Little Rock, Arkansas 72211
    United States

    Active - Recruiting

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