Effects of SIMEOX on Flow and Volume in Healthy Subjects and Patients With COPD
NCT ID: NCT04150601
Last Updated: 2023-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
48 participants
INTERVENTIONAL
2019-08-01
2021-11-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of SIMEOX on Static Hyperinflation in Patients With COPD
NCT04157972
CO2 Removal in Severe Acute exacerbatIons of Chronic Obstructive Lung Diseases
NCT05546606
Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and the Lung Availability of CHF 5993 in Healthy Volunteers
NCT02743013
Symptom-driven Maintenance and Reliever Treatment to Prevent Exacerbations in COPD
NCT02477397
Evaluation of Benefit of Nebulized Bronchodilators at Home in Severe Chronic Obstructive Pulmonary Disease and Very Severe Steady State
NCT02103374
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Participants will perform (1) a slow vital capacity, (2) a maximal expiration from total lung capacity to residual volume with SIMEOX, (3) a maximal expiration from total lung capacity to residual volume with a PEP device.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Spontaneous slow vital capacity
Participants will have to perform a slow vital capacity according to the guidelines, from total lung capacity to residual volume
Spontaneous Exhalation
A slow vital capacity maneuver will be performed according to the guidelines, from total lung capacity to residual volume
SIMEOX
Participants will have to perform a passive exhalation using the SIMEOX, starting from total lung capacity and going until achieving residual volume
SIMEOX
SIMEOX is a device generating a succession of gentle depression at the mouth.
PEP
Participants will have to perform an active exhalation using a PEP device, starting from total lung capacity and going until achieving residual volume
PEP
A PEP device (Pari-PEP) will be used to provoke a positive expiratory pressure while exhaling, thereby stabilizing the airways during expiration.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SIMEOX
SIMEOX is a device generating a succession of gentle depression at the mouth.
PEP
A PEP device (Pari-PEP) will be used to provoke a positive expiratory pressure while exhaling, thereby stabilizing the airways during expiration.
Spontaneous Exhalation
A slow vital capacity maneuver will be performed according to the guidelines, from total lung capacity to residual volume
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with COPD: able to understand the instructions; FEV1\<80% predicted value, naive to the SIMEOX device.
Exclusion Criteria
* Patients with COPD: obesity (BMI \> 30kg/m²); severe scoliosis; cardiovascular or neuromuscular disease.
45 Years
90 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
William Poncin, PT, PhD
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cliniques universitaires Saint-Luc
Brussels, Brussels Capital, Belgium
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SIMEOX-002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.