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NCT Number: NCT06836375

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Virgen del Rocio

Seville, Spain

Location contact

M. Auxiliadora Romero Falcon

PRINCIPAL_INVESTIGATOR

Mireia Munoz Rojo

CONTACT

[email protected]

+44 0208 1917590

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spirometry test with bronchodilation

Diagnostic 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 challenge

Diagnostic Test

test used to diagnose asthma where the patient breaths in methacholine

impulse oscillometry

Diagnostic 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 fraction

Other

Measure the level of nitric oxide in parts per billion (PPB) in the air the patient slowly exhales

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Orsina Dessi

CONTACT

[email protected]

+44 7721877020

Sponsors and collaborators

Lead sponsor

Acurable Ltd.

Industry

Registry information

Official study title

Estudio Piloto Para la aplicación de Dispositivos bioelectrónicos Externos de Baja Potencia en el diagnóstico de Asma Bronquial

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 20, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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