The Sweet Dreams Study - Accuracy of Sleep Trackers in Children

Recruiting

• Conditions: Sleep

• Registration Number: NCT06787378
• Lead Sponsor: Arkansas Children's Hospital Research Institute

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-01-15
• Study Start: 2025-03-01
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Primary Completion: 2029-02-28
• Study Completion: 2029-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total sleep time	Up to 10 days after consent	sleep minutes between lights off and lights on
Sleep efficiency	Up to 10 days after consent	Total sleep time divided by sleep period or number of total min from lights off to lights on
Wake after sleep onset	Up to 10 days after consent	wake minutes between PSG-scored sleep onset and lights on

Trial Locations

Locations (2)

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States

Arkansas Children's Nutrition Center; 🇺🇸 Little Rock, Arkansas, United States