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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02556567
• Other study ID #: 204310
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: December 2016

Study information

• Verified date: February 2024
• Source: Arkansas Children's Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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).

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
United States	Arkansas Children's Hospital Research Institute	Little Rock	Arkansas

Sponsors (3)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute	University of Arkansas, University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Machine Learning Techniques	Develop techniques to explore associations between Fitbit® data and patient reported outcome measures.	8 weeks
Primary	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.	8 weeks
Secondary	Risk of Increasing Asthma Symptoms	Identify risks of increasing asthma symptoms based on daily Fitbit® data from baseline over an 8 week time period.	8 weeks