An interventional study of AWARE in Asthma, COPD and Cystic Fibrosis, sponsored by Indiana University. Recruiting at 2 sites in United States. Open to participants aged 8 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Indiana University · Not applicable, Interventional, and Diagnostic
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.
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.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 800 is above the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 5, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
AWARE testing to estimate lung function and aid in disease diagnosis
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)
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Up to two weeks per subject
Reliable screening for disease diagnosis
Ability of AWARE to classify subjects into the study disease categories with adequate sensitivity (\>70%) and accuracy (\>50%) for use as a screening test
Time frame: Up to two weeks per subject
Screening of FEV1
Ability of AWARE to estimate FEV1 with acceptable accuracy (\<10% error) for use as a screening test.
Time frame: Up to two weeks per subject
Screening of FVC
Ability of AWARE to estimate FVC with acceptable accuracy (\<10% error) for use as a screening test
Time frame: Up to two weeks per subject
Screening of FEV1/FVC
Ability of AWARE to estimate FEV1/FVC with acceptable accuracy (\<10% error) for use as a screening test
Time frame: Up to two weeks per subject
Screening of FEF2575
Ability of AWARE to estimate FEF2575 with acceptable accuracy (\<10% error) for use as a screening test
Time frame: Up to two weeks per subject
Screening of R5
Ability of AWARE to estimate R5 with acceptable accuracy (\<20% error) for use as a screening test
Time frame: Up to two weeks per subject
Screening of R20
Ability of AWARE to estimate R20 with acceptable accuracy (\<20% error) for use as a screening test
Time frame: Up to two weeks per subject
Screening of R5-R20
Ability of AWARE to estimate R5-R20 with acceptable accuracy (\<20% error) for use as a screening test
Time frame: Up to two weeks per subject
Screening of X5
Ability of AWARE to estimate X5 with acceptable accuracy (\<20% error) for use as a screening test
Time frame: Up to two weeks per subject
Screening of AX
Ability of AWARE to estimate AX with acceptable accuracy (\<20% error) for use as a screening test
Time frame: Up to two weeks per subject
Screening of airway changes associated disease exacerbations
Ability of AWARE to identify disease exacerbations with adequate accuracy for use as a screening test (\>70% sensitivity and \>50% overall accuracy)
Time frame: Up to two weeks per subject
Started Jul 2024 (actual). Primary completion is estimated for Apr 2029, 57 months after the start.
Of 599 non-industry interventional studies with no phase under Asthma, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 50. This study's planned 57 months is above that.
Counting every sponsor, half of 649 studies reached it within 23 months; a quarter within 10 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.