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

Acurable

Status

Not yet enrolling

Conditions

Asthma Bronchiale

Treatments

Other: Measurement of the exhaled FeNO fraction

Diagnostic Test: Methacholine challenge

Diagnostic Test: impulse oscillometry

Diagnostic Test: Spirometry test with bronchodilation

Study type

Observational

Funder types

Industry

Identifiers

NCT06836375

1914-N-22

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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