Screening for Lung Health by a Mobile Device

NCT ID: NCT06232356

Last Updated: 2024-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

275 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-30

Study Completion Date

2024-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Diseases COPD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Mobile Web App

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SEPAR- EPOC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Universitario Virgen de las Nieves

Granada, , Spain

Site Status RECRUITING

Hospital Universitario La Paz

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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Bernardino Alcázar

Role: primary

958020127

Francisco García Rio

Role: primary

958020127

Other Identifiers

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SAP_SMILE_2864995

Identifier Type: -

Identifier Source: org_study_id

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