Computer Aided Respiratory Therapy Based on Audio and Spirometry Signals

Respiratory Therapy Clinical Trial

— COMPASS  

Official title:

Computer Aided Respiratory Therapy Based on Audio and Spirometry Signals

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06461195
• Other study ID #: 2023COMPASS-ST01
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 25, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: June 2024
• Source: Thomas More Kempen
• Contact: Kris Cuppens, PhD
• Phone: + 32 14 74 06 28
• Email: kris.cuppens[@]thomasmore.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to collect data: audio in the form of respiratory sounds and instructions from the therapist, spirometry data during the execution of the therapy, physiological parameters, and patient information. With the help of this data, algorithms will be developed for the automatic detection, localization, and classification of respiratory sounds, linked to the respiratory cycle using spirometric signals.

Description:

The study is an interventional study. Patients receive their standard respiratory physiotherapy, but in the mean time they are monitored with a stethoscope, spirometer and a wearable to measure physio-logical parameters.

It has been chosen to intervene as little as possible in the therapy to measure the respiratory sounds and breathing of the patient as accurately as possible. By recording therapy sessions with 15 patients, we expect to register several hundred events of respiratory sounds. This provides a good foundation for training an algorithm to detect and classify respiratory sounds.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: September 30, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• The patient has a chronic or acute respiratory condition and may need oxygen therapy

• The patient is minimally 12 years old

Exclusion Criteria:

• The patient is cognitively impaired.

• The patient has an undrained pneumothorax.

• The patient is experiencing an acute pulmonary hemorrhage.

• The patient is having an asthma exacerbation.

• The patient has an infection with Burkholderia cepatia.

• The patient is in isolation due to the risk of infection.

Related Conditions & MeSH terms

• Respiratory Therapy

Intervention

Other:
• Monitoring of patients
Data from a spirometer and a stethoscope are captured to develop algorithms to detect and classify respiration sounds to support therapists and patients in future therapy.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Lieven De Maesschalck	KU Leuven, Universitair Ziekenhuis Brussel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiration flow	Measured in liter per minute, measured by a spirometer.	1 year
Primary	Respiration volume	Measured in liter, measured by a spirometer.	1 year
Secondary	Heart rate	Measured in beats per minute by photoplethysmography using a wrist watch with a sensor	1 year
Secondary	Skin conductivity	Measured in Siemens using a wrist watch with a sensor	1 year
Secondary	Body temperature	Measured in degrees Celsius using a wrist watch with a sensor	1 year
Secondary	Oxygen saturation	Measured in percentage by photoplethysmography using a wrist watch with a sensor	1 year