Pilot Study for the Application of Low Power External Bioelectronic Devices in the Diagnosis of Bronchial Asthma.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spirometry test with bronchodilation, Methacholine challenge, impulse oscillometry, Measurement of the exhaled FeNO fraction.
- Who it may be relevant to
- Registry conditions: Asthma Bronchiale. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Estudio Piloto Para la aplicación de Dispositivos bioelectrónicos Externos de Baja Potencia en el diagnóstico de Asma Bronquial
Overview
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.
Interventions
- Diagnostic test 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 - Diagnostic test Methacholine challenge
test used to diagnose asthma where the patient breaths in methacholine - Diagnostic test 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 - Other Measurement of the exhaled FeNO fraction
Measure the level of nitric oxide in parts per billion (PPB) in the air the patient slowly exhales
Primary outcome measures
- Acoustic respiratory signals [Time frame: During the diagnostic tests performed and during the night studies performed by the participant for at least two weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Subject does not consent to the study
- Subject does not comply with inclusion criteria
- Subject has a known allergy to medical adhesives
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Hospital Virgen del Rocio — Seville
Identifiers
NCT: NCT06836375 · 1914-N-22