Pilot Study for the Application of Low Power External Bioelectronic Devices in the Diagnosis of Bronchial Asthma.

August 14, 2025 updated by: Acurable Ltd.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Sevilla, Spain
        • Hospital Virgen del Rocío
        • Contact:
        • Principal Investigator:
          • M. Auxiliadora Romero Falcon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients from or referred to the asthma unit in the hospital Virgen del Rocio in Seville, Spain

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Bronchial asthma
Patients with a diagnosis of bronchial asthma, under follow-up by the Asthma Unit.
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
Patients referred for consultation
Patients referred for consultation due to clinical suspicion of bronchial asthma.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the diagnostic tests performed and during the night studies performed by the participant for at least two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acurable Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 27, 2025

Primary Completion (Estimated)

February 27, 2026

Study Completion (Estimated)

February 27, 2027

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

February 18, 2025

First Posted (Actual)

February 20, 2025

Study Record Updates

Last Update Posted (Actual)

August 19, 2025

Last Update Submitted That Met QC Criteria

August 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1914-N-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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