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Clinical Trials/NCT06461195
NCT06461195
Not yet recruiting
Not Applicable

Computer Aided Respiratory Therapy Based on Audio and Spirometry Signals

Lieven De Maesschalck0 sites15 target enrollmentJune 25, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Therapy
Sponsor
Lieven De Maesschalck
Enrollment
15
Primary Endpoint
Respiration flow
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 25, 2024
End Date
September 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Lieven De Maesschalck
Responsible Party
Sponsor Investigator
Principal Investigator

Lieven De Maesschalck

Innovation Manager

Thomas More Kempen

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Respiration flow

Time Frame: 1 year

Measured in liter per minute, measured by a spirometer.

Respiration volume

Time Frame: 1 year

Measured in liter, measured by a spirometer.

Secondary Outcomes

  • Body temperature(1 year)
  • Skin conductivity(1 year)
  • Heart rate(1 year)
  • Oxygen saturation(1 year)

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