sefulness of Monitoring Using Breath Sound Analysis and Visualization System in Bronchial Asthma Patients

Phase 3

Recruiting

• Conditions: Respiratory sounds, wheezes, peak flow value, asthma control test; J459; Asthma or suspected asthma

• Registration Number: JPRN-jRCTs032230488
• Lead Sponsor: Ikemura Shinnosuke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-04
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients who meet all of the following criteria will be included in this study
(1) Patients who have given written consent to participate in this study
(2) Patients who are at least 18 years of age at the time consent is obtained
(3) Patients diagnosed with bronchial asthma (BA) or clinically suspected BA with wheezing or rhonchi on auscultation
(4) Have no acute illness other than asthma attack within 2 weeks prior to the date of consent
(5) Who understand and can actually use the Respiratory Sound Analysis and Visualization System's electronic stethoscope and respiratory sound analysis and recording application.

Exclusion Criteria

Patients who meet any of the following criteria will not be included in the study.
(1) Those who are unable to cooperate during the 15-day study period (i. Suffering from an active fatal acute disease requiring immediate therapeutic intervention such as myocardial infarction, cerebral infarction, or pulmonary embolus, ii. Has a pre-planned and difficult-to-modify examination or treatment such as surgery or chemotherapy; iii. Other unchangeable plans such as travel, weddings, funerals, etc.)
(2) Pregnant or lactating, or possibly pregnant
(3) Any other person whom the principal investigator (or subinvestigator) judges to be inappropriate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Coefficient of determination for single regression of peak flow value to percentage of own best value by quantitative value of breath sound analysis and visualization system on day0, day3, and day14

Secondary Outcome Measures

Name	Time	Method
(1)Correlation between quantitative value in breath sound analysis and visualization systems and ACT score on day0 and day14<br>(2)Correlation between quantitative value in breath sound analysis and visualization systems and exhaled NO on day0 and day14<br>(3)Correlation between quantitative value in breath sound analysis and visualization systems and FEV1 on day0 and day14<br>(4)Correlation between quantitative value in breath sound analysis and visualization systems and transcutaneous arterial blood oxygen saturation on day0 and day14