Acoustic Waveform Respiratory Evaluation

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT06512064
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
8 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • AWARE — DIAGNOSTIC_TEST
    AWARE testing to estimate lung function and aid in disease diagnosis

Study Details

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.

Key Dates

Start date
Jul 23, 2024
Status verified
Oct 2025
Primary completion
Apr 30, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
800 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Asthma
    Physician diagnosis plus at least one of the following in the past year: asthma symptoms that improve with albuterol; prescribed asthma controller medication(s); an acute asthma exacerbation requiring systemic steroids; or an emergency department visit or hospitalization for asthma. Alternatively, report of current asthma symptoms per US NAEPP or Global Initiative for Asthma (GINA) guidelines, plus documentation of bronchodilator response or airway hyperresponsiveness.
  • Experimental: Chronic Obstructive Pulmonary Disease (COPD)
    Physician diagnosis, plus symptoms of COPD per GOLD guidelines, plus post-bronchodilator FEV1/FVC \<0.70 or below the lower limit of normal (LLN) using GLI reference equations.
  • Experimental: Cystic Fibrosis (CF)
    Physician diagnosis based on U.S. CF Foundation guidelines, including signs/symptoms of CF and either a positive sweat chloride test (\>60 mmol/L), or an indeterminate sweat chloride test (30-59 mmol/L) plus two CF-causing CFTR mutations. The study may include subjects with different CFTR mutation classes as well as both on and off CFTR modulators.
  • Experimental: Other Airway Diseases
    This group will include subjects with airway ciliary motility disorders, bronchiectasis, and airway malaria. Given variability in the clinical presentation and diagnosis of these conditions, they will be ascertained by physician diagnosis and reviewed by study physician investigators.
  • Experimental: Healthy Controls
    This will include generally healthy subjects who do not have any of the airway diseases included in the study, nor other chronic cardiorespiratory or other diseases that may alter lung function or the ability to participate in the study.

Primary Outcome Measure

Accurate and reliable disease diagnosis [ Time Frame: Up to two weeks per subject ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Indiana UniversityIndianapolisIndiana46202
Erick Forno, MD MPH
University of PittsburghPittsburghPennsylvania15224
Juan C Celedón, MD DrPH

Find similar trials in Indianapolis, IN

By condition
AsthmaCOPD
By specialty
PulmonologyLung disease
By research site
Indiana University· Indianapolis, INUniversity of Pittsburgh· Pittsburgh, PA

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