Asthma BronchialeNCT06836375
Pilot Study for the Application of Low Power External Bioelectronic Devices in the Diagnosis of Bronchial Asthma.
An observational study of Asthma Bronchiale, run by Acurable Ltd. at 1 site in Spain.
Trial summary
The objective of this study is to detect the acoustic signals generated by the respiratory system on asthma patients using an acoustic sensor and retrospectively use these signals to identify the characteristics that differentiate patients with asthma and healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma Bronchiale
- What is being tested?
- Spirometry test with bronchodilation, Methacholine challenge and impulse oscillometry
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 27 Sep 2025to 27 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from or referred to the asthma unit in the hospital Virgen del Rocio in Seville, Spain
Who may be able to join
- Male or female, aged >= 18 and < 65.
- Ability to access applications on mobile device, technical understanding and minimal technological skills
- Subject has provided informed consent and is willing to comply with the study procedures.
Who cannot join
- Subject does not consent to the study
- Subject does not comply with inclusion criteria
- Subject has a known allergy to medical adhesives
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Virgen del Rocio
Seville
Mireia Munoz Rojo, +44 0208 1917590, mireia.munoz-rojo@acurable.com
M. Auxiliadora Romero Falcon
About this study
Official title: Estudio Piloto Para la aplicación de Dispositivos bioelectrónicos Externos de Baja Potencia en el diagnóstico de Asma Bronquial
The objective of this study is to detect the acoustic signals generated by the respiratory system on asthma patients using an acoustic sensor and retrospectively use these signals to identify the characteristics that differentiate patients with asthma and healthy subjects.
Read the detailed description
The objective of this project is to detect acoustic signals generated by the respiratory system in patients with asthma using the acoustic sensor; and then, retrospectively, to use these signals to carry out signal processing research, with the aim of trying to identify signal characteristics that can be used to differentiate asthma patients from people who do not have the disease.
The hypothesis, therefore, is that it is possible to target through external smart bioelectronic devices and wireless connectivity (wearables) the initial signals of the pathophysiology of bronchial asthma and differentiate them from the signals of the normal respiratory physiology of a healthy individual.
Similarly, detection of such signals would not only be useful for asthma diagnosis but also for monitoring and early detection of exacerbations before they can be detected by the usual respiratory functional tests.
The patients will first visit the asthma unit where the diagnostic tests will be undertaken. Then the subjects will take the acoustic sensor home with them and wear it during sleep for at least two weeks.
- Conditions
- Asthma Bronchiale
- Being tested
- Spirometry test with bronchodilation, Methacholine challenge, impulse oscillometry, Measurement of the exhaled FeNO fraction
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spirometry test with bronchodilationDiagnostic test
this test measures how much air you can breathe in and out of your lungs, as well as how easily and fast you can then blow the air out of your lungs
Methacholine challengeDiagnostic test
test used to diagnose asthma where the patient breaths in methacholine
impulse oscillometryDiagnostic test
test that uses sound waves to measure how much resistance there is to the normal movement of air in and out of your lungs when you are breathing at rest
Measurement of the exhaled FeNO fractionOther
Measure the level of nitric oxide in parts per billion (PPB) in the air the patient slowly exhales
| Study group | Role | What they receive |
|---|---|---|
| Patients with Bronchial asthma | Patients with a diagnosis of bronchial asthma, under follow-up by the Asthma Unit. Receives: Diagnostic Test: Spirometry test with bronchodilation; Diagnostic Test: Methacholine challenge; Diagnostic Test: impulse oscillometry; Other: Measurement of the exhaled FeNO fraction | |
| Patients referred for consultation | Patients referred for consultation due to clinical suspicion of bronchial asthma. Receives: Diagnostic Test: Spirometry test with bronchodilation; Diagnostic Test: Methacholine challenge; Diagnostic Test: impulse oscillometry; Other: Measurement of the exhaled FeNO fraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acoustic respiratory signals
Acoustic signals during the tests performed for asthma diagnosis and while the subjects sleep for at least two weeks.
Measured: During the diagnostic tests performed and during the night studies performed by the participant for at least two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start27 Sep 2025 (estimated)
- Primary completion27 Feb 2026 (estimated)
- Study completion27 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma BronchialeStudies 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acurable Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836375
- Sponsor's protocol ID
- 1914-N-22
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudio Piloto Para la aplicación de Dispositivos bioelectrónicos Externos de Baja Potencia en el diagnóstico de Asma Bronquial
- ClinicalTrials.gov ID
- NCT06836375
- Acronym / sponsor ID
- 1914-N-22
- Conditions
- Asthma Bronchiale
- Keywords
- Asthma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Acurable Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Sep 2025 (estimated)
- Primary completion
- 27 Feb 2026 (estimated)
- Study completion
- 27 Feb 2027 (estimated)
- First posted
- 20 Feb 2025 (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.
The objective of this study is to detect the acoustic signals generated by the respiratory system on asthma patients using an acoustic sensor and retrospectively use these signals to identify the characteristics that differentiate patients with asthma and healthy subjects.
Detailed description
The objective of this project is to detect acoustic signals generated by the respiratory system in patients with asthma using the acoustic sensor; and then, retrospectively, to use these signals to carry out signal processing research, with the aim of trying to identify signal characteristics that can be used to differentiate asthma patients from people who do not have the disease.
The hypothesis, therefore, is that it is possible to target through external smart bioelectronic devices and wireless connectivity (wearables) the initial signals of the pathophysiology of bronchial asthma and differentiate them from the signals of the normal respiratory physiology of a healthy individual.
Similarly, detection of such signals would not only be useful for asthma diagnosis but also for monitoring and early detection of exacerbations before they can be detected by the usual respiratory functional tests.
The patients will first visit the asthma unit where the diagnostic tests will be undertaken. Then the subjects will take the acoustic sensor home with them and wear it during sleep for at least two weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Bronchial asthma | – | Diagnostic Test: Spirometry test with bronchodilation, Diagnostic Test: Methacholine challenge, Diagnostic Test: impulse oscillometry, Other: Measurement of the exhaled FeNO fractionPatients with a diagnosis of bronchial asthma, under follow-up by the Asthma Unit. |
| Patients referred for consultation | – | Diagnostic Test: Spirometry test with bronchodilation, Diagnostic Test: Methacholine challenge, Diagnostic Test: impulse oscillometry, Other: Measurement of the exhaled FeNO fractionPatients referred for consultation due to clinical suspicion of bronchial asthma. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from or referred to the asthma unit in the hospital Virgen del Rocio in Seville, Spain
Key inclusion criteria (3 listed)
- Male or female, aged >= 18 and < 65.
- Ability to access applications on mobile device, technical understanding and minimal technological skills
- Subject has provided informed consent and is willing to comply with the study procedures.
Key exclusion criteria (3 listed)
- Subject does not consent to the study
- Subject does not comply with inclusion criteria
- Subject has a known allergy to medical adhesives
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 |
|---|---|---|
| Spirometry test with bronchodilationthis test measures how much air you can breathe in and out of your lungs, as well as how easily and fast you can then blow the air out of your lungs | Diagnostic test | Patients referred for consultation, Patients with Bronchial asthma |
| Methacholine challengetest used to diagnose asthma where the patient breaths in methacholine | Diagnostic test | Patients referred for consultation, Patients with Bronchial asthma |
| impulse oscillometrytest that uses sound waves to measure how much resistance there is to the normal movement of air in and out of your lungs when you are breathing at rest | Diagnostic test | Patients referred for consultation, Patients with Bronchial asthma |
| Measurement of the exhaled FeNO fractionMeasure the level of nitric oxide in parts per billion (PPB) in the air the patient slowly exhales | Other | Patients referred for consultation, Patients with Bronchial asthma |
Primary outcome
Acoustic respiratory signals
Time frame: During the diagnostic tests performed and during the night studies performed by the participant for at least two weeks
Acoustic signals during the tests performed for asthma diagnosis and while the subjects sleep for at least two weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma Bronchiale, run by Acurable Ltd. at 1 site 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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Orsina Dessi (+44 7721877020, orsina@acurable.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acoustic respiratory signals (time frame: During the diagnostic tests performed and during the night studies performed by the participant for at least two weeks). 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 19 Aug 2025.