About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 8-70 years (to ensure ability to perform other PFTs; up to 75 years for COPD subjects in the UPMC adult clinic only).
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
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
AWARE
Diagnostic testAWARE testing to estimate lung function and aid in disease diagnosis
Treatment groups
Trial outcomes
Primary outcomes
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)
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.
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.
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).
Secondary outcomes
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
Screening of FEV1
Ability of AWARE to estimate FEV1 with acceptable accuracy (\<10% error) for use as a screening test.
Screening of FVC
Ability of AWARE to estimate FVC with acceptable accuracy (\<10% error) for use as a screening test
Screening of FEV1/FVC
Ability of AWARE to estimate FEV1/FVC with acceptable accuracy (\<10% error) for use as a screening test
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Indiana University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
University of Pittsburgh
Collaborator