CClinicalTrials.gg
Not yet recruitingNCT06461195COMPASSUpdated Jun 14, 2024

Computer Aided Respiratory Therapy Based on Audio and Spirometry Signals

An interventional study of Monitoring of patients in Respiratory Therapy, sponsored by Lieven De Maesschalck. Not yet recruiting. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-06-14.

Sponsored by Lieven De Maesschalck · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
12 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Respiratory Therapy

Keywords

  • Spirometry
  • Respiratory sounds
03

In context

Lead sponsor

Lieven De Maesschalck is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • 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

Interventions

  • OtherMonitoring 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.

06

What researchers measure

Primary outcomes

  1. Respiration flow

    Measured in liter per minute, measured by a spirometer.

    Time frame: 1 year

  2. Respiration volume

    Measured in liter, measured by a spirometer.

    Time frame: 1 year

Secondary outcomes

  1. Heart rate

    Measured in beats per minute by photoplethysmography using a wrist watch with a sensor

    Time frame: 1 year

  2. Skin conductivity

    Measured in Siemens using a wrist watch with a sensor

    Time frame: 1 year

  3. Body temperature

    Measured in degrees Celsius using a wrist watch with a sensor

    Time frame: 1 year

  4. Oxygen saturation

    Measured in percentage by photoplethysmography using a wrist watch with a sensor

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06461195
Lead sponsor
Lieven De Maesschalck
Collaborators
KU Leuven, Universitair Ziekenhuis Brussel
Responsible party
Lieven De Maesschalck (Innovation Manager, Thomas More Kempen) — Sponsor-investigator
First posted
Jun 14, 2024
Start date
Jun 25, 2024 (estimated)
Primary completion
Mar 1, 2025 (estimated)
Completion
Sep 30, 2025 (estimated)
Last update
Jun 14, 2024

Study contacts

Kris Cuppens, PhD
Contact
kris.cuppens@thomasmore.be
+ 32 14 74 06 28
Filip Van Ginderdeuren, PhD
Contact
filip.vanginderdeuren@uzbrussel.be
Filip Van Ginderdeuren, PhD
principal investigator · Universitair Ziekenhuis Brussel

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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