Screening for Lung Health by a Mobile Device

Recruiting

• Conditions: Lung Diseases; COPD
• Interventions: Diagnostic Test: Mobile Web App

• Registration Number: NCT06232356
• Lead Sponsor: SEPAR- EPOC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-30
• Status Verified: 2024-01
• Study First Submitted: 2024-01-18
• Study First Submitted QC: 2024-01-28
• Last Update Submitted: 2024-01-28
• Study First Posted: 2024-01-30
• Last Update Posted: 2024-01-30
• Primary Completion: 2024-09-01
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 275

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study population	Mobile Web App	The study population will consist of adult subjects (healthy or with respiratory disease - COPD) between 18 and 80 years of age, who will be enrolled in the pulmonary function laboratories of the participating hospitals, from among those listed above, who are attended to a functional respiratory examination.

Primary Outcome Measures

Name	Time	Method
Main Outcome	At the time of assessment	Proportion of lung function abnormalities (defined as FEV1/FVC\<0.7 or LLN) detected with the mobile app

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome	At the time of assessment	Proportion of lung function abnormalities (defined as FVC \<80% predicted or LLN) detected with the mobile app

Trial Locations

Locations (2)

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain