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

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ClinicalTrials.gov Identifier: NCT02556567
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : October 8, 2020
Sponsor:
Collaborators:
University of Arkansas
University of Florida
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Asthma Other: Fitbit® Charge Heart Rate (HR) wristband Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Exploring the Effects of Sleep Patterns and Physical Activity on Asthma in Adolescents With Wrist-worn Smart Devices
Actual Study Start Date : August 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Intervention
Participants will wear the Fitbit® Charge Heart Rate (HR) wristband for eight weeks.
Other: 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 Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Machine Learning Techniques [ Time Frame: 8 weeks ]
    Develop techniques to explore associations between Fitbit® data and patient reported outcome measures.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556567


Locations
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United States, Arkansas
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
University of Arkansas
University of Florida
Investigators
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Principal Investigator: Tamara T. Perry, MD University of Arkansas
Publications of Results:
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Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02556567    
Other Study ID Numbers: 204310
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to share individual participant data. We will disseminate our research findings in medical sponsored journals, presentations and posters.
Keywords provided by Arkansas Children's Hospital Research Institute:
Sleep patterns
Physical activity
Fitbit
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases