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Recruiting NCT06512064

Acoustic Waveform Respiratory Evaluation

No phase Interventional Asthma COPD Cystic Fibrosis Ciliary Motility Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AWARE.
Who it may be relevant to
Registry conditions: Asthma, COPD, Cystic Fibrosis, Ciliary Motility Disorders. Basic parameters: 8 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Diagnostic test AWARE
    AWARE testing to estimate lung function and aid in disease diagnosis

Primary outcome measures

  • Accurate and reliable disease diagnosis [Time frame: Up to two weeks per subject]
  • Estimation of FEV1 [Time frame: Up to two weeks per subject]
  • Estimation of FVC [Time frame: Up to two weeks per subject]
  • Estimation of FEV1/FVC [Time frame: Up to two weeks per subject]
  • Estimation of FEF2575 [Time frame: Up to two weeks per subject]
  • Estimation of R5 [Time frame: Up to two weeks per subject]
  • Estimation of R20 [Time frame: Up to two weeks per subject]
  • Estimation of R5-R20 [Time frame: Up to two weeks per subject]
  • Estimation of X5 [Time frame: Up to two weeks per subject]
  • Estimation of AX [Time frame: Up to two weeks per subject]
Secondary outcome measures (11)
  • Reliable screening for disease diagnosis [Time frame: Up to two weeks per subject]
  • Screening of FEV1 [Time frame: Up to two weeks per subject]
  • Screening of FVC [Time frame: Up to two weeks per subject]
  • Screening of FEV1/FVC [Time frame: Up to two weeks per subject]
  • Screening of FEF2575 [Time frame: Up to two weeks per subject]
  • Screening of R5 [Time frame: Up to two weeks per subject]
  • Screening of R20 [Time frame: Up to two weeks per subject]
  • Screening of R5-R20 [Time frame: Up to two weeks per subject]
  • Screening of X5 [Time frame: Up to two weeks per subject]
  • Screening of AX [Time frame: Up to two weeks per subject]
  • Screening of airway changes associated disease exacerbations [Time frame: Up to two weeks per subject]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 2 centers
  • Indiana University — Indianapolis
  • University of Pittsburgh — Pittsburgh

Identifiers

NCT: NCT06512064 · 20030 · R01HL170368

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗