Screening for Lung Health by a Mobile Device

COPD Clinical Trial

— SMILE  

Official title:

Respiratory Health Screening Using a Mobile Device

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06232356
• Other study ID #: SAP_SMILE_2864995
• Status: Recruiting
• Start date: December 30, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: January 2024
• Source: SEPAR- EPOC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 275
• Est. completion date: October 31, 2024
• Est. primary completion date: September 1, 2024
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COPD
• Lung Diseases

Intervention

Diagnostic Test:
• Mobile Web App
all participants will undergo an assessment of respiratory health by analyzing the sound of exhaled air recorded by the participant's mobile phone

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
SEPAR- EPOC

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Main Outcome	Proportion of lung function abnormalities (defined as FEV1/FVC<0.7 or LLN) detected with the mobile app	At the time of assessment
Secondary	Secondary Outcome	To analize the diagnostic performance from web app to detect different lung function abnormalities	At the time of assessment
Secondary	Secondary Outcome	To evaluate concordancy between lung function estimates obtained with a mobile app and spirometers	At the time of assessment
Secondary	Secondary Outcome	Proportion of lung function abnormalities (defined as FVC <80% predicted or LLN) detected with the mobile app	At the time of assessment