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

Not yet recruiting

• Conditions: Asthma Bronchiale

• Registration Number: NCT06836375
• Lead Sponsor: Acurable Ltd.

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-18
• Last Update Submitted: 2025-02-18
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-20
• Study Start: 2025-02-27
• Primary Completion: 2026-02-27
• Study Completion: 2027-02-27

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acoustic respiratory signals	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.

Trial Locations

Locations (1)

Hospital Virgen del Rocio; 🇪🇸 Sevilla, Spain