Respiratory TherapyCOMPASSNCT06461195
Computer Aided Respiratory Therapy Based on Audio and Spirometry Signals
A study testing Monitoring of patients in people with Respiratory Therapy, run by Lieven De Maesschalck.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Respiratory Therapy
- What is being tested?
- Monitoring of patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patient has a chronic or acute respiratory condition and may need oxygen therapy
- The patient is minimally 12 years old
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Filip Van Ginderdeuren, PhD contact
About this study
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.
- Conditions
- Respiratory Therapy
- Being tested
- Monitoring of patients
- Keywords
- Spirometry, Respiratory sounds
- Medical subject headings
- Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring of patientsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Regular respiratory physiotherapy while being monitored | Experimental | 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. Receives: Other: Monitoring of patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiration flow
Measured in liter per minute, measured by a spirometer.
Measured: 1 year
Respiration volume
Measured in liter, measured by a spirometer.
Measured: 1 year
Secondary outcomes (4)
Heart rate
Measured in beats per minute by photoplethysmography using a wrist watch with a sensor
Measured: 1 year
Skin conductivity
Measured in Siemens using a wrist watch with a sensor
Measured: 1 year
Body temperature
Measured in degrees Celsius using a wrist watch with a sensor
Measured: 1 year
Oxygen saturation
Measured in percentage by photoplethysmography using a wrist watch with a sensor
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start25 Jun 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group interventional study acquiring spirometry data, respiration sound and physiological data in patients suffering from pulmonary disease.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lieven De Maesschalck
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, Universitair Ziekenhuis Brussel
- Responsible party
- Sponsor-investigator, Lieven De Maesschalck, Thomas More Kempen
- Investigators
- Filip Van Ginderdeuren, PhD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461195
- Sponsor's protocol ID
- 2023COMPASS-ST01
- Acronym
- COMPASS
- Status last verified
- Jun 2024
- First submitted
- 19 Apr 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Aided Respiratory Therapy Based on Audio and Spirometry Signals
- ClinicalTrials.gov ID
- NCT06461195
- Acronym / sponsor ID
- COMPASS / 2023COMPASS-ST01
- Conditions
- Respiratory Therapy
- Keywords
- Spirometry, Respiratory sounds
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Lieven De MaesschalckUniversity, hospital or other
- Collaborators
- KU Leuven, Universitair Ziekenhuis Brussel
- Study start
- 25 Jun 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group interventional study acquiring spirometry data, respiration sound and physiological data in patients suffering from pulmonary disease.
| Arm | Type | Receives |
|---|---|---|
| Regular respiratory physiotherapy while being monitored | Experimental | Other: Monitoring of patientsPatients receive their standard respiratory physiotherapy, but in the mean time they are monitored with a stethoscope, spirometer and a wearable to measure physiological parameters. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- The patient has a chronic or acute respiratory condition and may need oxygen therapy
- The patient is minimally 12 years old
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring of patientsData 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. | Other | Regular respiratory physiotherapy while being monitored |
Primary outcome
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.
4 secondary outcomes
Heart rate
Time frame: 1 year
Skin conductivity
Time frame: 1 year
Body temperature
Time frame: 1 year
Oxygen saturation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filip Van Ginderdeuren, PhD contact
Filip Van Ginderdeuren, PhD principal investigator
Universitair Ziekenhuis Brussel
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring of patients in people with Respiratory Therapy, run by Lieven De Maesschalck.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kris Cuppens, PhD (+ 32 14 74 06 28, kris.cuppens@thomasmore.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiration flow (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024; AzTrials last refreshed its copy on 29 Oct 2026.