Screening for Lung Health by a Mobile Device

NCT06232356 | Unknown

• 1 other identifier: SAP_SMILE_2864995
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Diseases; COPD

Keywords

Spirometry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Secondary Outcome

  At the time of assessment

• Secondary Outcome

  At the time of assessment

• Secondary Outcome

  At the time of assessment

Study Arms (1)

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

Interventions

Mobile Web App DIAGNOSTIC_TEST

all participants will undergo an assessment of respiratory health by analyzing the sound of exhaled air recorded by the participant's mobile phone

Study population

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Contraindication to perform any of the protocol procedures
• Inability to answer the study questionnaires.

Sponsors & Collaborators

• SEPAR- EPOC: lead

Study Sites (2)

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Lung Diseases; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 30, 2024
• Study Start: December 30, 2023
• Primary Completion: September 1, 2024
• Study Completion: October 31, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

ES (2)