Clinical trial NCT06512064: Acoustic Waveform Respiratory Evaluation
Official title: Advancing Telemedicine in Pulmonology: Acoustic-waveform Respiratory Evaluation (AWARE) Via Sensing and Machine Learning on Smartphones
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma
COPD
Cystic Fibrosis
Ciliary Motility Disorders
Bronchiectasis
Airway Malacia
Healthy Control
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Pittsburgh
First posted: 2024-07-22
Enrollment: 800
Sex: ALL
Minimum age (years): 8
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Accurate and reliable disease diagnosis
timeFrame: Up to two weeks per subject
measure: Estimation of FEV1
timeFrame: Up to two weeks per subject
measure: Estimation of FVC
timeFrame: Up to two weeks per subject
measure: Estimation of FEV1/FVC
timeFrame: Up to two weeks per subject
measure: Estimation of FEF2575
timeFrame: Up to two weeks per subject
measure: Estimation of R5
timeFrame: Up to two weeks per subject
measure: Estimation of R20
timeFrame: Up to two weeks per subject
measure: Estimation of R5-R20
timeFrame: Up to two weeks per subject
measure: Estimation of X5
timeFrame: Up to two weeks per subject
measure: Estimation of AX
timeFrame: Up to two weeks per subject
measure: Identification of airway changes associated disease exacerbations
timeFrame: Up to two weeks per subject
Secondary outcomes:
measure: Reliable screening for disease diagnosis
timeFrame: Up to two weeks per subject
measure: Screening of FEV1
timeFrame: Up to two weeks per subject
measure: Screening of FVC
timeFrame: Up to two weeks per subject
measure: Screening of FEV1/FVC
timeFrame: Up to two weeks per subject
measure: Screening of FEF2575
timeFrame: Up to two weeks per subject
measure: Screening of R5
timeFrame: Up to two weeks per subject
measure: Screening of R20
timeFrame: Up to two weeks per subject
measure: Screening of R5-R20
timeFrame: Up to two weeks per subject
measure: Screening of X5
timeFrame: Up to two weeks per subject
measure: Screening of AX
timeFrame: Up to two weeks per subject
measure: Screening of airway changes associated disease exacerbations
timeFrame: Up to two weeks per subject
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: Indiana University
name: Erick Forno, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: