Computer Aided Respiratory Therapy Based on Audio and Spirometry Signals

Not Applicable

Not yet recruiting

• Conditions: Respiratory Therapy
• Interventions: Other: Monitoring of patients

• Registration Number: NCT06461195
• Lead Sponsor: Lieven De Maesschalck

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-04-19
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-11
• Last Update Submitted: 2024-06-11
• Study First Posted: 2024-06-14
• Last Update Posted: 2024-06-14
• Study Start: 2024-06-25
• Primary Completion: 2025-03-01
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Regular respiratory physiotherapy while being monitored	Monitoring of patients	Patients receive their standard respiratory physiotherapy, but in the mean time they are monitored with a stethoscope, spirometer and a wearable to measure physiological parameters.

Primary Outcome Measures

Name	Time	Method
Respiration flow	1 year	Measured in liter per minute, measured by a spirometer.
Respiration volume	1 year	Measured in liter, measured by a spirometer.

Secondary Outcome Measures

Name	Time	Method
Body temperature	1 year	Measured in degrees Celsius using a wrist watch with a sensor
Skin conductivity	1 year	Measured in Siemens using a wrist watch with a sensor
Heart rate	1 year	Measured in beats per minute by photoplethysmography using a wrist watch with a sensor
Oxygen saturation	1 year	Measured in percentage by photoplethysmography using a wrist watch with a sensor