Finding Correlations Between Asthma Exacerbation, Physiological Measurements and Environmental Factors

NCT04845932 | Recruiting

• 1 other identifier: 16598
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To identify asthma-related physiological changes observed by wearable devices in real-world conditions by monitor multiple sensing modalities (e.g., heart rate (HR), heart rate variability (HRV), activity level, spirometry, coughing sounds) in order to find reliable signatures of impending asthma exacerbation and systematically explore any challenges on the use of wearable technologies.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Identify the correlation between continuous physiological measurements, inhaler usage and lung function outcomes from spirometry

  Physiological measurements obtained from wearable devices (including motion, heart rate and heart rate variability) and from acoustic sensors (including audio from cough) will be correlated with outcomes from the daily spirometry measurements and inhaler use. Hand-crafted and data-driven features will be extracted for physiological measurements. Standard statistical tests will be used to determine significant correlations.

  Continuously from baseline and up to 4 months

Secondary Outcomes (1)

• Develop a predictive model for asthma exacerbation and drop in lung function based on physiological measurements and inhaler usage

  Continuously from baseline and up to 4 months

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents with asthma will be included

You may qualify if:

• Adolescents (14-18 years old) with asthma will be included.
• Participants should have Wireless Internet access at their homes
• Individuals with COVID-19 symptoms will be automatically excluded due to their clinical screening prior to their clinic visit. However, if a participant contracts COVID-19 during the study, they will be encouraged to continue participating since all interactions will be remote after the first clinical screening.
• Adolescents should be able to use a iOS device (provided by the researchers) and the devices (with assistance from parents when appropriate) for data collection efforts. They cannot participate in this study if they don't feel comfortable with operating the multiple devices including the iOS device. The iOS device can only be used for the purposes of this study. The iOS device will be restricted by enabling Parental Control Settings accessible only to the researchers.
• The participation of an adolescent may be terminated by the investigator if they do not follow the guidelines for the study, including using the devices as instructed or participating in the interviews and weekly surveys. Also, the monthly renewal for the participation of the study (up to 4 months) will be decided by the investigators on a month-by-month basis given that the participant also agrees to continue in the study.
• Individuals with physical challenges are allowed to be incidentally included as long as they satisfy all the previous criteria.

You may not qualify if:

• none listed

Sponsors & Collaborators

• North Carolina State University: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

UNC Children's Raleigh Clinic

Raleigh, North Carolina, 27607, United States

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Katie Mills

CONTACT

919-966-2936; katherine.mills@unc.edu

Edgar Lobaton

CONTACT

919-515-5151; edgar.lobaton@ncsu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Dept. of Electrical and Computer Engineering

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 15, 2021
• Study Start: September 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

US (1)