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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorAcurable Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Subject does not consent to the study

Subject does not comply with inclusion criteria

Subject has a known allergy to medical adhesives

Trial population

Patients from or referred to the asthma unit in the hospital Virgen del Rocio in Seville, Spain

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Patients with Bronchial asthma4 interventions
Group B: Patients referred for consultation4 interventions

Trial outcomes

Primary outcomes

1

Acoustic respiratory signals

Acoustic signals during the tests performed for asthma diagnosis and while the subjects sleep for at least two weeks.

Time frame
During the diagnostic tests performed and during the night studies performed by the participant for at least two weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: