Screening for Lung Health by a Mobile Device (SMILE)

SEPAR- EPOC

Status: Enrolling

Conditions: Lung Diseases; COPD

Treatments: Diagnostic Test: Mobile Web App

Study type: Observational

Funder types: Other

Identifiers

NCT06232356

SAP_SMILE_2864995

Details and patient eligibility

About

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.

Enrollment: 275 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

275 participants in 1 patient group

Study population

Description:

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.

Treatment:

Diagnostic Test: Mobile Web App