Acoustic Waveform Respiratory Evaluation

NCT ID: NCT06512064

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-23
• Study Completion Date: 2029-04-30

Brief 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.

Detailed Description

Asthma and COPD respectively affect millions of people in the US. Chronic lower respiratory diseases represented the fourth leading cause of death in the country before the pandemic. For these and other pulmonary diseases like cystic fibrosis (CF), monitoring disease remotely but objectively could lead to marked improvements in disease control, quality of life, and overall prognosis. However, current disease monitoring and management often rely on subjective symptom report, and objective pulmonary function tests (PFTs) are often only done a handful of times a year at subspecialty referral centers. The primary hypothesis for this study is that smartphone-based sensing and machine learning (ML) approaches can advance pulmonary telemedicine by enabling comprehensive pulmonary disease evaluation with high accuracy, reliability, and adaptability. The investigators further hypothesize that AWARE can accurately help identify different lung diseases, estimate lung function, and detect changes associated with exacerbations. In Aim 1, investigators will develop and improve a smartphone sensing approach as an accurate and reliable aide in airway disease diagnosis. Investigators will recruit a sample of healthy individuals and individuals with asthma, COPD, CF, and other airway diseases, to assess whether AWARE can accurately classify subjects in their disease groups. In Aim 2, investigators will improve the ML approach to estimate lung function accurately and adaptively, including traditional PFT indices from spirometry and impulse oscillometry. And in Aim 3, investigators will develop deep learning techniques to identify changes in airway conditions associated disease exacerbations, by performing AWARE during stable disease and acute exacerbations. For these aims, investigators will recruit a cohort of pediatric and adult subjects with a wide range of demographic and anthropometric characteristics, to have adequate representation of various airway diseases, a broad range of lung function, and the ability to obtain measurements during acute disease exacerbations. The study protocol will include study questionnaires, anthropometry, body composition, and three sets of PFTs: spirometry, oscillometry, and AWARE. A subgroup of subjects will additionally perform AWARE at home for up to two weeks, allowing investigators to evaluate supervised vs unsupervised and in-clinic vs. at-home measurements. Similarly, a subgroup of subjects will perform AWARE dual testing (i.e., with both study smartphones and their own smartphone) to evaluate repeatability using diverse equipment and software platforms.

Conditions

Asthma; COPD; Cystic Fibrosis; Ciliary Motility Disorders; Bronchiectasis; Airway Malacia; Healthy Control

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

AWARE

Intervention Type: DIAGNOSTIC_TEST

AWARE testing to estimate lung function and aid in disease diagnosis

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.

Group Type: EXPERIMENTAL

AWARE

Intervention Type: DIAGNOSTIC_TEST

AWARE testing to estimate lung function and aid in disease diagnosis

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.

Group Type: EXPERIMENTAL

AWARE

Intervention Type: DIAGNOSTIC_TEST

AWARE testing to estimate lung function and aid in disease diagnosis

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.

Group Type: EXPERIMENTAL

AWARE

Intervention Type: DIAGNOSTIC_TEST

AWARE testing to estimate lung function and aid in disease diagnosis

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.

Group Type: EXPERIMENTAL

AWARE

Intervention Type: DIAGNOSTIC_TEST

AWARE testing to estimate lung function and aid in disease diagnosis

Interventions

AWARE

AWARE testing to estimate lung function and aid in disease diagnosis

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Age 8-70 years

2. Ability to perform spirometry and oscillometry

3. Signed informed consent (and assent for children as appropriate)

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

Exclusion Criteria

1. Inability or unwillingness to perform AWARE, spirometry, or oscillometry

2. Acute or chronic illness that, at the judgement of investigators, may affect lung function and alter the results of AWARE or the reference PFTs (spirometry and AOS)

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Erick Forno

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erick Forno, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University

Indianapolis, Indiana, United States

Site Status: RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elizabeth Rizzi, RN

Role: CONTACT

lizbuell@iu.edu

317-626-6937

Lisa Bendy, RRT

Role: CONTACT

lbendy@iu.edu

317-278-7152

Facility Contacts

Erick Forno, MD MPH

Role: primary

Juan C Celedón, MD DrPH

Role: primary

Other Identifiers

R01HL170368

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20030

Identifier Type: -

Identifier Source: org_study_id