Acoustic Waveform Respiratory Evaluation
NCT Number: NCT06512064
Acronym: AWARE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Asthma|COPD|Cystic Fibrosis|Ciliary Motility Disorders|Bronchiectasis|Airway Malacia|Healthy Control
Interventions: DIAGNOSTIC_TEST: AWARE
Sponsor: Indiana University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)|University of Pittsburgh
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 800
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07
Completion Date: 2029-07
Locations: Indiana University, Indianapolis, Indiana, 46202, United States|University of Pittsburgh, Pittsburgh, Pennsylvania, 15224, United States

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.

Primary Outcome Measures: 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), 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., 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., 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)., 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)., 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., 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., 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., 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., 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., 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)., Up to two weeks per subject
Secondary Outcome Measures: 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, 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., 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, 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, 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, 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, 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, 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, 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, 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, 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), Up to two weeks per subject