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Clinical Trials/NCT06232356
NCT06232356
Recruiting
Not Applicable

Respiratory Health Screening Using a Mobile Device

SEPAR- EPOC2 sites in 1 country275 target enrollmentDecember 30, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Diseases
Sponsor
SEPAR- EPOC
Enrollment
275
Locations
2
Primary Endpoint
Main Outcome
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Respiratory diseases are a common cause of mortality and disability at the worldwide and national levels. Many of them are characterized by underdiagnosis and diagnosis in advanced stages of the disease, and in most of them, forced spirometry is one of the fundamental tools to assess the diagnosis and seriousness of the disease.

To help in improving the detection of respiratory diseases and the understanding of the respiratory health of the general population, one possible solution would be to develop a mobile application that could assess respiratory health by using the sound signal of exhaled air recorded by a mobile microphone.

This project will aim to validate a mobile application (WebApp) for the detection of pulmonary function disorders. It is planned to recruit 267 subjects, with and without respiratory disease, who are attended in pulmonary function laboratories of 10 Spanish hospitals, to compare the sensitivity of this application in the diagnosis of pulmonary function disorders (either obstructive patterns or PRISm) versus the gold standard (spirometry). Ease of use and user satisfaction with the application will also be assessed.

Registry
clinicaltrials.gov
Start Date
December 30, 2023
End Date
October 31, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
SEPAR- EPOC
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult subjects with age range between 18 and 80 years old
  • Signing the informed consent form
  • Subjects scheduled for respiratory function tests at the pulmonary function laboratory for clinical reasons
  • Having a cell phone and be willing to install the application

Exclusion Criteria

  • Contraindication to perform any of the protocol procedures
  • Inability to answer the study questionnaires.

Outcomes

Primary Outcomes

Main Outcome

Time Frame: At the time of assessment

Proportion of lung function abnormalities (defined as FEV1/FVC\<0.7 or LLN) detected with the mobile app

Secondary Outcomes

  • Secondary Outcome(At the time of assessment)

Study Sites (2)

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