Actively Recruiting

Phase Not Applicable
Age: 8Years - 70Years
All Genders
Healthy Volunteers
ID06512064

Advancing Telemedicine in Pulmonology: Acoustic-waveform Respiratory Evaluation (AWARE) via Sensing and Machine Learning on Smartphones

Led by Indiana University · Updated on 2025-10-24

800

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

I

Indiana University

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of smartphone speakers and microphones to assess airway size, detect airway obstruction, assist in diagnosing airway diseases, and identify disease flare-ups. This study focuses on chronic respiratory diseases such as asthma, COPD, cystic fibrosis, and other airway conditions. The goal is to improve remote monitoring of lung disease using smartphone-based sensing combined with machine learning techniques, aiming for more accurate, reliable, and adaptable pulmonary telemedicine. Participants will undergo a diagnostic test called AWARE, which uses smartphone technology to estimate lung function and support disease diagnosis. The study includes groups with asthma, COPD, cystic fibrosis, other airway diseases, and healthy controls. Participants will complete questionnaires, body measurements, and three types of pulmonary function tests: spirometry, oscillometry, and AWARE. Some will perform AWARE at home for up to two weeks, and a subgroup will test with study smartphones and their own devices to assess repeatability across different platforms. During the study, participants will be assessed through lung function tests, questionnaires, and body composition measurements. Researchers will monitor outcomes such as accurate disease diagnosis, estimation of lung function indices, and detection of airway changes during exacerbations. The study measures will be collected over up to two weeks per participant. This involves supervised and unsupervised testing both in clinics and at home, allowing comprehensive evaluation of the AWARE approach's reliability and clinical utility.

CONDITIONS

Brief Title

Acoustic Waveform Respiratory Evaluation

Who Can Participate

Age: 8Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 8 and 70 years
  • Ability to perform spirometry and oscillometry lung tests
  • Signed informed consent (and assent for children as appropriate)
  • Physician diagnosis of asthma, COPD, cystic fibrosis, or other airway diseases, or no respiratory or major diseases for healthy controls
Not Eligible

You will not qualify if you...

  • Unable or unwilling to perform AWARE, spirometry, or oscillometry tests
  • Acute or chronic illness that may affect lung function and alter study test results as judged by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to two weeks per subject

Participants undergo AWARE testing along with spirometry and oscillometry tests to estimate lung function and aid in disease diagnosis.

1 baseline visit and up to 14 days of at-home AWARE testing for some participants

Trial Site Locations

Total: 2 locations

1

Indiana University

Indianapolis, Indiana, United States, 46202

Actively Recruiting

2

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15224

Actively Recruiting

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Research Team

E

Elizabeth Rizzi, RN

L

Lisa Bendy, RRT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

5

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