Overview

This trial is active, not recruiting.

Condition asthma
Treatment fitbit® charge heart rate (hr) wristband
Sponsor Arkansas Children's Hospital Research Institute
Collaborator University of Arkansas
Start date August 2015
End date June 2016
Trial size 23 participants
Trial identifier NCT02556567, 204310

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Arm
(Other)
Participants will wear the Fitbit® Charge Heart Rate (HR) wristband for eight weeks.
fitbit® charge heart rate (hr) wristband
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

Measure
Asthma Symptoms , Sleep Patterns and Physical Activity
time frame: 8 weeks

Secondary Outcomes

Measure
Risk of Increasing Asthma Symptoms
time frame: 8 weeks

Eligibility Criteria

Male or female participants from 14 years up to 17 years old.

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).

Additional Information

Official title Exploring the Effects of Sleep Patterns and Physical Activity on Asthma in Adolescents With Wrist-worn Smart Devices
Principal investigator Tamara T. Perry, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Arkansas Children's Hospital Research Institute.