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

JRCT ID: jRCTs032230488

Registered date:04/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Asthma or suspected asthma
• Date of first enrollment: 07/11/2024
• Target sample size: 30
• Study type: Interventional

Intervention(s)

(1) Prescribe asthma medications (controller and reliever) on day 0 and instruct patients to use them as prescribed.
(2) On day 0, instruct patients on the auscultation procedure as follows.
a. Measure twice a day (morning and evening). However, when symptoms appear, additional measurements should be taken before and after using the reliever.
b. Perform auscultation with an electronic stethoscope (total of 4 specific left and right anterior chest areas).
Auscultation findings are automatically recorded on the server.
c. Then measure and record the peak flow value in the asthma diary.
(3) Confirm asthma medications from day 0 at the return visit on day 14. Retrieve electronic stethoscope, and breath sound analysis and recording application.

Outcome(s)

• Primary Outcome: 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

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Ikemura Shinnosuke
• Secondary Sponsor: Soejima Kenzo
• Source(s) of Monetary Support: AIR WATER INC.,University of Yamanashi