Exploring the Effects of Sleep Patterns and Physical Activity on Asthma in Adolescents With Wrist-worn Smart Devices

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Other: Fitbit® Charge Heart Rate (HR) wristband

• Registration Number: NCT02556567
• Lead Sponsor: Arkansas Children's Hospital Research Institute

Brief Summary

This is a research study to find associations between asthma symptoms and sleep patterns and physical activity among adolescent patients with persistent asthma. The Investigators will collect Fitbit® sensor data and survey data from each adolescent enrolled in the study.

Detailed Description

Investigators from the University of Arkansas for Medical Sciences (Pediatrics), the University of Arkansas at Little Rock and the University of Florida will work together to conduct a research study to find associations between asthma symptoms, sleep patterns, and physical activity over an 8-week period among adolescent patients with persistent asthma.

The goal of this research study is to find new ways for teenagers to manage their asthma. Full understanding of the connection and interference of sleep patterns and physical activity with asthma symptoms will be very helpful for teenagers with asthma to better manage their daily routine and asthma care. This research study will use wrist-worn devices (i.e. Fitbit® wristbands) to collect participants' sleep and physical activity data.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-08
• Study First Submitted QC: 2015-09-21
• Study First Posted: 2015-09-22
• Primary Completion: 2016-06
• Study Completion: 2016-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

1. Age ≥ 14 and ≤ 17 years;
2. Teen access to a mobile smartphone device with a data plan or a computer with reliable internet connection, compatible with the Fitbit® application during the study period;
3. Diagnosis of mild, moderate or severe persistent asthma per National Heart Lung Blood Institute (NHLBI).

Exclusion Criteria

1. Current smokers and adolescents with significant underlying respiratory disease other than asthma (such as cystic fibrosis) that could potentially interfere with asthma-related outcome measures;
2. Prior diagnosis of sleep disorder;
3. Patients with significant co-morbid conditions (such as moderate to severe developmental delay) that could interfere with the adolescent's ability to self-monitor asthma;
4. Inability to speak or understand English (child or parent).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Fitbit® Charge Heart Rate (HR) wristband	Participants will wear the Fitbit® Charge Heart Rate (HR) wristband for eight weeks.

Primary Outcome Measures

Name	Time	Method
Asthma Symptoms , Sleep Patterns and Physical Activity	8 weeks	Fitbit built-in sensors (e.g., accelerometer, gyroscope, and heart rate sensors will measure disruptive sleep patterns, decreased levels of physical activity and asthma symptoms using response pattern scoring from baseline for 8 weeks.

Secondary Outcome Measures

Name	Time	Method
Risk of Increasing Asthma Symptoms	8 weeks	Identify risks of increasing asthma symptoms based on daily Fitbit® data from baseline over an 8 week time period.

Trial Locations

Locations (1)

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