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

Primary Purpose

Asthma

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Fitbit® Charge Heart Rate (HR) wristband

About this trial

This is an interventional other trial for Asthma focused on measuring Sleep patterns, Physical activity, Fitbit

Eligibility Criteria

14 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

Arkansas Children's Hospital Research Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Asthma Symptoms , Sleep Patterns and Physical Activity

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

Risk of Increasing Asthma Symptoms

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

Full Information

NCT ID

NCT02556567

First Posted

September 8, 2015

Last Updated

October 6, 2020

Sponsor

Arkansas Children's Hospital Research Institute

Collaborators

University of Arkansas, University of Florida

1. Study Identification

Unique Protocol Identification Number

NCT02556567

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

August 2015 (Actual)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Arkansas Children's Hospital Research Institute

Collaborators

University of Arkansas, University of Florida

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Sleep patterns, Physical activity, Fitbit

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Fitbit® Charge Heart Rate (HR) wristband

Intervention Description

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 Measure Information:

Title

Asthma Symptoms , Sleep Patterns and Physical Activity

Description

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Risk of Increasing Asthma Symptoms

Description

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

Time Frame

8 weeks

Other Pre-specified Outcome Measures:

Title

Machine Learning Techniques

Description

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

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tamara T. Perry, MD

Organizational Affiliation

University of Arkansas

Official's Role

Principal Investigator

Facility Information:

Facility Name

Arkansas Children's Hospital Research Institute

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72202

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

We do not plan to share individual participant data. We will disseminate our research findings in medical sponsored journals, presentations and posters.

Citations:

PubMed Identifier

17947969

Citation

Moorman JE, Rudd RA, Johnson CA, King M, Minor P, Bailey C, Scalia MR, Akinbami LJ; Centers for Disease Control and Prevention (CDC). National surveillance for asthma--United States, 1980-2004. MMWR Surveill Summ. 2007 Oct 19;56(8):1-54.

Results Reference

result

PubMed Identifier

19221156

Citation

Akinbami LJ, Moorman JE, Garbe PL, Sondik EJ. Status of childhood asthma in the United States, 1980-2007. Pediatrics. 2009 Mar;123 Suppl 3:S131-45. doi: 10.1542/peds.2008-2233C.

Results Reference

result

PubMed Identifier

9565412

Citation

Calmes D, Leake BD, Carlisle DM. Adverse asthma outcomes among children hospitalized with asthma in California. Pediatrics. 1998 May;101(5):845-50. doi: 10.1542/peds.101.5.845.

Results Reference

result

PubMed Identifier

17272582

Citation

Smaldone A, Honig JC, Byrne MW. Sleepless in America: inadequate sleep and relationships to health and well-being of our nation's children. Pediatrics. 2007 Feb;119 Suppl 1:S29-37. doi: 10.1542/peds.2006-2089F.

Results Reference

result

PubMed Identifier

24796650

Citation

Walker TJ, Reznik M. In-school asthma management and physical activity: children's perspectives. J Asthma. 2014 Oct;51(8):808-13. doi: 10.3109/02770903.2014.920875. Epub 2014 May 14.

Results Reference

result

PubMed Identifier

25213049

Citation

Meltzer LJ, Ullrich M, Szefler SJ. Sleep duration, sleep hygiene, and insomnia in adolescents with asthma. J Allergy Clin Immunol Pract. 2014 Sep-Oct;2(5):562-9. doi: 10.1016/j.jaip.2014.02.005. Epub 2014 Apr 13.

Results Reference

result

PubMed Identifier

23525551

Citation

Wanrooij VH, Willeboordse M, Dompeling E, van de Kant KD. Exercise training in children with asthma: a systematic review. Br J Sports Med. 2014 Jul;48(13):1024-31. doi: 10.1136/bjsports-2012-091347. Epub 2013 Mar 23.

Results Reference

result

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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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