Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06787378

The Sweet Dreams Study - Accuracy of Sleep Trackers in Children

Status
Recruiting
Phase
Study type
Observational
Enrollment
300 (estimated)
Sponsor
Arkansas Children's Hospital Research Institute · Academic / Other
Sex
All
Age
2 Years – 17 Years
Healthy volunteers
Accepted

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.

Conditions

Timeline

Start date
2025-03-01
Primary completion
2029-02-28
Completion
2029-02-28
First posted
2025-01-22
Last updated
2025-04-03

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT06787378. Inclusion in this directory is not an endorsement.