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Screening for Lung Health by a Mobile Device

Respiratory Health Screening Using a Mobile Device

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06232356
Acronym
SMILE
Enrollment
275
Registered
2024-01-30
Start date
2023-12-30
Completion date
2024-10-31
Last updated
2024-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Lung Diseases

Keywords

Spirometry

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.

Interventions

DIAGNOSTIC_TESTMobile 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

Sponsors

SEPAR- EPOC
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Main OutcomeAt the time of assessmentProportion of lung function abnormalities (defined as FEV1/FVC\<0.7 or LLN) detected with the mobile app

Secondary

MeasureTime frameDescription
Secondary OutcomeAt the time of assessmentTo analize the diagnostic performance from web app to detect different lung function abnormalities

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026