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AWARE: Smartphone-based Lung Function Evaluation

This study is testing a new diagnostic tool called AWARE, which uses smartphone speakers and microphones to assess lung function. The goal is to see if AWARE can accurately identify airway obstruction, help diagnose lung diseases like asthma, COPD (chronic obstructive pulmonary disease), cystic fibrosis, and bronchiectasis, and detect when these conditions worsen. Researchers hope this technology can make it easier to monitor lung health remotely. You might be able to join if you are between 8 and 70 years old and can perform standard breathing tests (spirometry and oscillometry). The study will measure how accurately AWARE can diagnose diseases and estimate your lung function within two weeks.

Study design
This interventional study plans to enroll 800 participants. The phase of the study is not specified.
What's involved
You would need to be able to perform AWARE testing, spirometry, and oscillometry. The primary endpoints are measured up to two weeks per subject.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured up to two weeks per subject.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06512064

Acoustic Waveform Respiratory Evaluation

Recruiting
NAAges 8–70InterventionalDiagnostic
Indiana University
~800 participants
Updated 2025-10-24 on ClinicalTrials.gov
What's tested:AWARE

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Accurate and reliable disease diagnosis
Measured over Up to two weeks per subject
+10 more outcomes measured

Conditions

Asthma
COPD
Cystic Fibrosis
Ciliary Motility Disorders
Bronchiectasis
Airway Malacia
Healthy Control

Explore related trials

Airway malaciaAsthmaBronchiectasisChronic Obstructive Pulmonary DiseaseCiliary Motility DefectCystic FibrosisHealthy Control

Where it's being run

2 sites across 2 states
Indiana1
Pennsylvania1

Study leadership

  • Erick Forno, MD MPH · PRINCIPAL_INVESTIGATOR · Indiana University

Who to contact

Elizabeth Rizzi, RN
[email protected]
317-626-6937
Email the study team

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What this trial measures

  • Accurate and reliable disease diagnosisUp to two weeks per subject

    Ability of AWARE to accurately classify subjects into the study disease categories with high accuracy (\>80% sensitivity and \>80% overall accuracy)

  • Estimation of FEV1Up to two weeks per subject

    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 FVCUp to two weeks per subject

    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/FVCUp to two weeks per subject

    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).

  • Estimation of FEF2575Up to two weeks per subject

    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).

  • Estimation of R5Up to two weeks per subject

    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.

  • Estimation of R20Up to two weeks per subject

    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.

  • Estimation of R5-R20Up to two weeks per subject

    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.

  • Estimation of X5Up to two weeks per subject

    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.

  • Estimation of AXUp to two weeks per subject

    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.

  • Identification of airway changes associated disease exacerbationsUp to two weeks per subject

    Ability of AWARE to identify disease exacerbations (\>80% sensitivity and \>80% overall accuracy).