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Completed

NCT Number: NCT02556567

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

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.

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Key information

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, 72202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age ≥ 14 and ≤ 17 years;
  • 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;
  • Diagnosis of mild, moderate or severe persistent asthma per National Heart Lung Blood Institute (NHLBI).

Exclusion criteria

  • 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;
  • Prior diagnosis of sleep disorder;
  • 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;
  • Inability to speak or understand English (child or parent).

Treatment and study plan

Fitbit® Charge Heart Rate (HR) wristband

Other

The Investigators will conduct a proof of concept and feasibility study to explore associations between asthma symptoms and sleep patterns and physical activity over an 8-week intervention period among 20 adolescent patients with persistent asthma.

Primary outcomes

  1. Asthma Symptoms , Sleep Patterns and Physical Activity

    Time frame: 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 outcomes

  1. Risk of Increasing Asthma Symptoms

    Time frame: 8 weeks

    Identify risks of increasing asthma symptoms based on daily Fitbit® data from baseline over an 8 week time period.

Other outcomes

  1. Machine Learning Techniques

    Time frame: 8 weeks

    Develop techniques to explore associations between Fitbit® data and patient reported outcome measures.

Sponsors and collaborators

Lead sponsor

Arkansas Children's Hospital Research Institute

Other

Collaborators

  • University of Arkansas
  • University of Florida

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 22, 2015
Registry last updated
Jul 31, 2024

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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