Computer Aided Respiratory Therapy Based on Audio and Spirometry Signals (COMPASS)

June 11, 2024 updated by: Lieven De Maesschalck
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Regular respiratory physiotherapy while being monitored
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiration flow
Time Frame: 1 year
Measured in liter per minute, measured by a spirometer.
1 year
Respiration volume
Time Frame: 1 year
Measured in liter, measured by a spirometer.
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lieven De Maesschalck

Collaborators

KU Leuven
Universitair Ziekenhuis Brussel

Investigators

  • Principal Investigator: Filip Van Ginderdeuren, PhD, Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 25, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

April 19, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

June 14, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023COMPASS-ST01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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