Acoustic Waveform Respiratory Evaluation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-70
SponsorIndiana University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • AWARE

    Diagnostic test

    AWARE testing to estimate lung function and aid in disease diagnosis

Treatment groups

800 Participants
are divided into 5 treatment groups
Group A: AsthmaExperimental treatment 1 intervention
Group B: Chronic Obstructive Pulmonary Disease (COPD)Experimental treatment 1 intervention
Group C: Cystic Fibrosis (CF)Experimental treatment 1 intervention
Group D: Other Airway DiseasesExperimental treatment 1 intervention
Group E: Healthy ControlsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

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