NCT06836375

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
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Acurable Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma Bronchiale

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-09-27
• Primary completion: 2026-02-27
• Completion: 2027-02-27
• First posted: 2025-02-20
• Last updated: 2025-08-19

Locations

1 site across 1 country: Spain