Advancing Telemedicine in Pulmonology: Acoustic-waveform Respiratory Evaluation (AWARE) Via Sensing and Machine Learning on Smartphones

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The study will evaluate the feasibility of using smartphone speakers and microphones to evaluate the caliber of the airways, detect airway obstruction, aid in airway disease diagnosis, and identify disease exacerbations.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 65
Healthy Volunteers: t
View:

• Age 8-65 years

• Ability to perform spirometry and oscillometry

• Signed informed consent (and assent for children as appropriate)

• No respiratory or other major disease (for healthy controls), or physician-diagnosed asthma, COPD, CF, or other airway diseases

Locations
United States
Indiana
Indiana University
RECRUITING
Indianapolis
Pennsylvania
University of Pittsburgh
RECRUITING
Pittsburgh
Contact Information
Primary
Elizabeth Rizzi, RN
lizbuell@iu.edu
317-626-6937
Backup
Lisa Bendy, RRT
lbendy@iu.edu
317-278-7152
Time Frame
Start Date: 2024-07-23
Estimated Completion Date: 2029-04
Participants
Target number of participants: 800
Treatments
Experimental: Asthma
Physician diagnosis plus at least one of the following in the past year: asthma symptoms that improve with albuterol; prescribed asthma controller medication(s); an acute asthma exacerbation requiring systemic steroids; or an emergency department visit or hospitalization for asthma. Alternatively, report of current asthma symptoms per US NAEPP or Global Initiative for Asthma (GINA) guidelines, plus documentation of bronchodilator response or airway hyperresponsiveness.
Experimental: Chronic Obstructive Pulmonary Disease (COPD)
Physician diagnosis, plus symptoms of COPD per GOLD guidelines, plus post-bronchodilator FEV1/FVC \<0.70 or below the lower limit of normal (LLN) using GLI reference equations.
Experimental: Cystic Fibrosis (CF)
Physician diagnosis based on U.S. CF Foundation guidelines, including signs/symptoms of CF and either a positive sweat chloride test (\>60 mmol/L), or an indeterminate sweat chloride test (30-59 mmol/L) plus two CF-causing CFTR mutations. The study may include subjects with different CFTR mutation classes as well as both on and off CFTR modulators.
Experimental: Other Airway Diseases
This group will include subjects with airway ciliary motility disorders, bronchiectasis, and airway malaria. Given variability in the clinical presentation and diagnosis of these conditions, they will be ascertained by physician diagnosis and reviewed by study physician investigators.
Experimental: Healthy Controls
This will include generally healthy subjects who do not have any of the airway diseases included in the study, nor other chronic cardiorespiratory or other diseases that may alter lung function or the ability to participate in the study.
Sponsors
Collaborators: University of Pittsburgh, National Heart, Lung, and Blood Institute (NHLBI)
Leads: Indiana University

This content was sourced from clinicaltrials.gov