Screening for Lung Health by a Mobile Device (SMILE)

Respiratory Health Screening Using a Mobile Device

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Diseases; COPD
• Intervention / Treatment: Diagnostic test: Mobile Web App

• Study Type: Observational
• Enrollment (Estimated): 275

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18014
    • Recruiting
    • Hospital Universitario Virgen de las Nieves
    • Contact: Bernardino Alcázar; Phone Number: 958020127; Email: bernardino.alcazar.sspa@juntadeandalucia.es
  • Madrid, Spain
    • Recruiting
    • Hospital Universitario La Paz
    • Contact: Francisco García Rio; Phone Number: 958020127; Email: bernardino.alcazar.sspa@juntadeandalucia.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study population; 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: SEPAR- EPOC

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: January 28, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 28, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Spirometry
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: SAP_SMILE_2864995

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No