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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06836375
Enrollment
50
Registered
2025-02-20
Start date
2025-09-27
Completion date
2027-02-27
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma Bronchiale

Keywords

Asthma

Brief 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.

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_TESTSpirometry 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_TESTMethacholine challenge

test used to diagnose asthma where the patient breaths in methacholine

DIAGNOSTIC_TESTimpulse 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

OTHERMeasurement of the exhaled FeNO fraction

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

Sponsors

Acurable Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Acoustic respiratory signalsDuring the diagnostic tests performed and during the night studies performed by the participant for at least two weeksAcoustic signals during the tests performed for asthma diagnosis and while the subjects sleep for at least two weeks.

Countries

Spain

Contacts

Primary ContactOrsina Dessi
orsina@acurable.com+44 7721877020

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026