Computer Aided Respiratory Therapy Based on Audio and Spirometry Signals

NCT06461195 | Not Yet Recruiting DMC

• 1 other identifier: 2023COMPASS-ST01
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Respiratory Therapy

Keywords

Spirometry; Respiratory sounds

Outcome Measures

Primary Outcomes (2)

• Respiration flow

  Measured in liter per minute, measured by a spirometer.

  1 year

• Respiration volume

  Measured in liter, measured by a spirometer.

  1 year

Secondary Outcomes (4)

• Heart rate

  1 year

• Skin conductivity

  1 year

• Body temperature

  1 year

• Oxygen saturation

  1 year

Study Arms (1)

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.

Other: Monitoring of patients

Interventions

Monitoring of patients OTHER

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.

Regular respiratory physiotherapy while being monitored

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has a chronic or acute respiratory condition and may need oxygen therapy
• The patient is minimally 12 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lieven De Maesschalck: lead
• KU Leuven: collaborator
• Universitair Ziekenhuis Brussel: collaborator

MeSH Terms

Conditions

Respiratory Sounds

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Filip Van Ginderdeuren, PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kris Cuppens, PhD

CONTACT

+ 32 14 74 06 28; kris.cuppens@thomasmore.be

Filip Van Ginderdeuren, PhD

CONTACT

filip.vanginderdeuren@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Innovation Manager

Model Details: Single group interventional study acquiring spirometry data, respiration sound and physiological data in patients suffering from pulmonary disease.

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: June 14, 2024
• Study Start: June 25, 2024
• Primary Completion: March 1, 2025
• Study Completion: September 30, 2025
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share