Acoustic Waveform Respiratory Evaluation

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06512064
• Lead Sponsor: Indiana University

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.

Study Timeline

• Study First Submitted: 2024-06-26
• Status Verified: 2024-07
• Study Start: 2024-07
• Study First Submitted QC: 2024-07-15
• Last Update Submitted: 2024-07-15
• Study First Posted: 2024-07-22
• Last Update Posted: 2024-07-22
• Primary Completion: 2029-04
• Study Completion: 2029-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

1. Age 8-65 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Estimation of FEV1	Up to two weeks per subject	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.
Accurate and reliable disease diagnosis	Up to two weeks per subject	Ability of AWARE to accurately classify subjects into the study disease categories with high accuracy (\>80% sensitivity and \>80% overall accuracy)
Estimation of R5	Up to two weeks per subject	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.
Estimation of AX	Up to two weeks per subject	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.
Estimation of X5	Up to two weeks per subject	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.
Estimation of FVC	Up to two weeks per subject	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.
Estimation of FEV1/FVC	Up to two weeks per subject	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).
Estimation of FEF2575	Up to two weeks per subject	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).
Estimation of R20	Up to two weeks per subject	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.
Estimation of R5-R20	Up to two weeks per subject	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.
Identification of airway changes associated disease exacerbations	Up to two weeks per subject	Ability of AWARE to identify disease exacerbations (\>80% sensitivity and \>80% overall accuracy).

Secondary Outcome Measures

Name	Time	Method
Screening of R5	Up to two weeks per subject	Ability of AWARE to estimate R5 with acceptable accuracy (\<20% error) for use as a screening test
Screening of X5	Up to two weeks per subject	Ability of AWARE to estimate X5 with acceptable accuracy (\<20% error) for use as a screening test
Screening of AX	Up to two weeks per subject	Ability of AWARE to estimate AX with acceptable accuracy (\<20% error) for use as a screening test
Reliable screening for disease diagnosis	Up to two weeks per subject	Ability of AWARE to classify subjects into the study disease categories with adequate sensitivity (\>70%) and accuracy (\>50%) for use as a screening test
Screening of FVC	Up to two weeks per subject	Ability of AWARE to estimate FVC with acceptable accuracy (\<10% error) for use as a screening test
Screening of FEF2575	Up to two weeks per subject	Ability of AWARE to estimate FEF2575 with acceptable accuracy (\<10% error) for use as a screening test
Screening of R5-R20	Up to two weeks per subject	Ability of AWARE to estimate R5-R20 with acceptable accuracy (\<20% error) for use as a screening test
Screening of airway changes associated disease exacerbations	Up to two weeks per subject	Ability of AWARE to identify disease exacerbations with adequate accuracy for use as a screening test (\>70% sensitivity and \>50% overall accuracy)
Screening of FEV1/FVC	Up to two weeks per subject	Ability of AWARE to estimate FEV1/FVC with acceptable accuracy (\<10% error) for use as a screening test
Screening of FEV1	Up to two weeks per subject	Ability of AWARE to estimate FEV1 with acceptable accuracy (\<10% error) for use as a screening test.
Screening of R20	Up to two weeks per subject	Ability of AWARE to estimate R20 with acceptable accuracy (\<20% error) for use as a screening test

Trial Locations

Locations (2)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States