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
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2025
CompletedFirst Posted
Study publicly available on registry
February 20, 2025
CompletedStudy Start
First participant enrolled
September 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2027
ExpectedAugust 19, 2025
February 1, 2025
5 months
February 13, 2025
August 14, 2025
Conditions
Keywords
Outcome Measures
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.
During the diagnostic tests performed and during the night studies performed by the participant for at least two weeks
Study Arms (2)
Patients with Bronchial asthma
Patients with a diagnosis of bronchial asthma, under follow-up by the Asthma Unit.
Patients referred for consultation
Patients referred for consultation due to clinical suspicion of bronchial asthma.
Interventions
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
test used to diagnose asthma where the patient breaths in methacholine
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
Measure the level of nitric oxide in parts per billion (PPB) in the air the patient slowly exhales
Eligibility Criteria
Patients from or referred to the asthma unit in the hospital Virgen del Rocio in Seville, Spain
You may qualify if:
- 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.
You may not qualify if:
- Subject does not consent to the study
- Subject has a known allergy to medical adhesives
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Acurable Ltd.lead
Study Sites (1)
Hospital Virgen del Rocio
Seville, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2025
First Posted
February 20, 2025
Study Start
September 27, 2025
Primary Completion
February 27, 2026
Study Completion (Estimated)
February 27, 2027
Last Updated
August 19, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share