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NCT Number: NCT06787378

The Sweet Dreams Study - Accuracy of Sleep Trackers in Children

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.

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Key information

Conditions

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Arkansas Children's Hospital, Little Rock, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Total sleep time

    Time frame: Up to 10 days after consent

    sleep minutes between lights off and lights on

  2. Wake after sleep onset

    Time frame: Up to 10 days after consent

    wake minutes between PSG-scored sleep onset and lights on

  3. Sleep efficiency

    Time frame: Up to 10 days after consent

    Total sleep time divided by sleep period or number of total min from lights off to lights on

Study contacts

Contact information is provided by the study sponsor or research team.

Eva C Diaz, MD

CONTACT

[email protected]

5013646056

Tonja Nolen

CONTACT

[email protected]

501-364-2853

Sponsors and collaborators

Lead sponsor

Arkansas Children's Hospital Research Institute

Other

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jan 22, 2025
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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