Lung DiseasesSMILENCT06232356
Screening for Lung Health by a Mobile Device
An observational study of Lung Diseases and COPD, run by SEPAR- EPOC at 2 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Diseases, COPD
- What is being tested?
- Mobile Web App
- How many people
- 275 participants
- Where
- 2 sitesSpain
- Study dates
- 30 Dec 2023to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Contraindication to perform any of the protocol procedures
- Inability to answer the study questionnaires.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Virgen de las Nieves
Granada, 18014
Bernardino Alcázar, 958020127, bernardino.alcazar.sspa@juntadeandalucia.es
- Recruiting
Hospital Universitario La Paz
Madrid
Francisco García Rio, 958020127, bernardino.alcazar.sspa@juntadeandalucia.es
About this study
Official title: 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.
- Conditions
- Lung Diseases, COPD
- Being tested
- Mobile Web App
- Keywords
- Spirometry
- Medical subject headings
- Lung Diseases, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Web AppDiagnostic 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Mobile Web App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main Outcome
Proportion of lung function abnormalities (defined as FEV1/FVC<0.7 or LLN) detected with the mobile app
Measured: At the time of assessment
Secondary outcomes (3)
Secondary Outcome
To analize the diagnostic performance from web app to detect different lung function abnormalities
Measured: At the time of assessment
Secondary Outcome
To evaluate concordancy between lung function estimates obtained with a mobile app and spirometers
Measured: At the time of assessment
Secondary Outcome
Proportion of lung function abnormalities (defined as FVC <80% predicted or LLN) detected with the mobile app
Measured: At the time of assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start30 Dec 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SEPAR- EPOC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232356
- Sponsor's protocol ID
- SAP_SMILE_2864995
- Acronym
- SMILE
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Health Screening Using a Mobile Device
- ClinicalTrials.gov ID
- NCT06232356
- Acronym / sponsor ID
- SMILE / SAP_SMILE_2864995
- Conditions
- Lung Diseases, COPD
- Keywords
- Spirometry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- SEPAR- EPOCUniversity, hospital or other
- Study start
- 30 Dec 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | Diagnostic Test: Mobile Web AppThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Contraindication to perform any of the protocol procedures
- Inability to answer the study questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Web Appall participants will undergo an assessment of respiratory health by analyzing the sound of exhaled air recorded by the participant's mobile phone | Diagnostic test | Study population |
Primary outcome
Main Outcome
Time frame: At the time of assessment
Proportion of lung function abnormalities (defined as FEV1/FVC<0.7 or LLN) detected with the mobile app
3 secondary outcomes
Secondary Outcome
Time frame: At the time of assessment
Secondary Outcome
Time frame: At the time of assessment
Secondary Outcome
Time frame: At the time of assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hospital Universitario Virgen de las Nieves
Granada, Spain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases and COPD, run by SEPAR- EPOC at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main Outcome (time frame: At the time of assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.