Pilot Study for the Application of Low Power External Bioelectronic Devices in the Diagnosis of Bronchial Asthma.
NCT ID: NCT06836375
Last Updated: 2025-08-19
Study Results
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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NOT_YET_RECRUITING
50 participants
OBSERVATIONAL
2025-09-27
2027-02-27
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with Bronchial asthma
Patients with a diagnosis of bronchial asthma, under follow-up by the Asthma Unit.
Spirometry test with bronchodilation
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 challenge
test used to diagnose asthma where the patient breaths in methacholine
impulse oscillometry
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 fraction
Measure the level of nitric oxide in parts per billion (PPB) in the air the patient slowly exhales
Patients referred for consultation
Patients referred for consultation due to clinical suspicion of bronchial asthma.
Spirometry test with bronchodilation
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 challenge
test used to diagnose asthma where the patient breaths in methacholine
impulse oscillometry
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 fraction
Measure the level of nitric oxide in parts per billion (PPB) in the air the patient slowly exhales
Interventions
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Spirometry test with bronchodilation
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 challenge
test used to diagnose asthma where the patient breaths in methacholine
impulse oscillometry
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 fraction
Measure the level of nitric oxide in parts per billion (PPB) in the air the patient slowly exhales
Eligibility Criteria
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Inclusion Criteria
* 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.
* Subject has a known allergy to medical adhesives
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Acurable Ltd.
INDUSTRY
Responsible Party
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Locations
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Hospital Virgen del Rocio
Seville, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1914-N-22
Identifier Type: -
Identifier Source: org_study_id
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