Acoustic Waveform Respiratory Evaluation

NCT06512064 | Recruiting FDA Device

• 2 other identifiers: 20030R01HL170368
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (11)

• Accurate and reliable disease diagnosis

  Ability of AWARE to accurately classify subjects into the study disease categories with high accuracy (\>80% sensitivity and \>80% overall accuracy)

  Up to two weeks per subject

• Estimation of FEV1

  Ability of AWARE to estimate FEV1 with high accuracy (\<5% error compared to spirometry measures). FEV1 (forced expiratory volume in 1 second) is a measurement of how much air a person can exhale in the first second after inhaling.

  Up to two weeks per subject

• Estimation of FVC

  Ability of AWARE to estimate FVC with high accuracy (\<5% error compared to spirometry measures). FVC (forced vital capacity) is a measurement of the maximum amount of air a person can exhale after a deep breath in.

  Up to two weeks per subject

• Estimation of FEV1/FVC

  Ability of AWARE to estimate FEV1/FVC with high accuracy (\<5% error compared to spirometry measures). FEV1/FVC is the proportion of the forced vital capacity (FVC) that is exhaled in the first second (FEV1).

  Up to two weeks per subject

• Estimation of FEF2575

  Ability of AWARE to estimate FEF2575 with high accuracy (\<5% error compared to spirometry measures). FEF25-75% is defined as forced expiratory flow over the middle one-half of the FVC (the average flow from the point at which 25% of the FVC has been exhaled to the point at which 75% of the FVC has been exhaled).

  Up to two weeks per subject

• Estimation of R5

  Ability of AWARE to estimate R5 with high accuracy (\<10% error compared to oscillometry measures). R5 (also known as Rrs5), assessed by oscillometry, is the airway resistance to sound waves at a frequency of 5 Hz.

  Up to two weeks per subject

• Estimation of R20

  Ability of AWARE to estimate R20 with high accuracy (\<10% error compared to oscillometry measures). R20 (also known as Rrs20), assessed by oscillometry, is the airway resistance to sound waves at a frequency of 20 Hz.

  Up to two weeks per subject

• Estimation of R5-R20

  Ability of AWARE to estimate R5-R20 with high accuracy (\<10% error compared to oscillometry measures). R5-R20 (also known as Rrs5-Rrs20) is a measurement of small airway dysfunction typically assessed via oscillometry in which the difference in airway resistance to sound waves of 5 Hz and 20 Hz is calculated.

  Up to two weeks per subject

• Estimation of X5

  Ability of AWARE to estimate X5 with high accuracy (\<10% error compared to oscillometry measures). X5 (also known as Xrs5), assessed by oscillometry, is the airway reactance to sound waves at a frequency of 5 Hz.

  Up to two weeks per subject

• Estimation of AX

  Ability of AWARE to estimate AX with high accuracy (\<10% error compared to oscillometry measures). AX (area of reactance) is a lung function measurement of the lung's ability to store energy for passive expiration obtained via oscillometry. AX is measured by the area under the reactance curve from lowest frequency to the resonant frequency.

  Up to two weeks per subject

• Identification of airway changes associated disease exacerbations

  Ability of AWARE to identify disease exacerbations (\>80% sensitivity and \>80% overall accuracy).

  Up to two weeks per subject

Secondary Outcomes (11)

• Reliable screening for disease diagnosis

  Up to two weeks per subject

• Screening of FEV1

  Up to two weeks per subject

• Screening of FVC

  Up to two weeks per subject

• Screening of FEV1/FVC

  Up to two weeks per subject

• Screening of FEF2575

  Up to two weeks per subject

Study Arms (5)

Asthma

EXPERIMENTAL

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.

Diagnostic Test: AWARE

Chronic Obstructive Pulmonary Disease (COPD)

EXPERIMENTAL

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.

Diagnostic Test: AWARE

Cystic Fibrosis (CF)

EXPERIMENTAL

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.

Diagnostic Test: AWARE

Other Airway Diseases

EXPERIMENTAL

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.

Diagnostic Test: AWARE

Healthy Controls

EXPERIMENTAL

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.

Diagnostic Test: AWARE

Interventions

AWARE DIAGNOSTIC_TEST

AWARE testing to estimate lung function and aid in disease diagnosis

Asthma; Chronic Obstructive Pulmonary Disease (COPD); Cystic Fibrosis (CF); Healthy Controls; Other Airway Diseases

Eligibility Criteria

• Age: 8 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 8-70 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

You may not qualify if:

• Inability or unwillingness to perform AWARE, spirometry, or oscillometry
• 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)

Sponsors & Collaborators

• Indiana University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Pittsburgh: collaborator

Study Sites (2)

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive; Cystic Fibrosis; Ciliary Motility Disorders; Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Otorhinolaryngologic Diseases; Ciliopathies; Abnormalities, Multiple; Congenital Abnormalities

Study Officials

• Erick Forno, MD MPH

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Rizzi, RN

CONTACT

317-626-6937; lizbuell@iu.edu

Lisa Bendy, RRT

CONTACT

317-278-7152; lbendy@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 22, 2024
• Study Start: July 23, 2024
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: October 24, 2025

Record last verified: 2025-10

Locations

US (2)