Pulmonary Disease, Chronic ObstructiveNCT04157972
Effects of SIMEOX on Static Hyperinflation in Patients With COPD
A study testing SIMEOX and PEP in people with Pulmonary Disease, Chronic Obstructive, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
This study will investigate the effects on the SIMEOX technology on static hyperinflation in patients with chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- SIMEOX and PEP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Aug 2019to 16 Mar 2021
- 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 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic obstructive pulmonary disease,
- Forced expiratory volume in 1s (FEV1) <80% of predicted value,
- Stable condition (no pulmonary exacerbation for more than 28 days).
Who cannot join
- Routine use of one of the two treatments - SIMEOX and/or PEP,
- Inability to understand or carry out the instructions,
- Severe cardiac comorbidity, neuromuscular disease,
- Severe scoliosis,
- Patient with a pacemaker.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Cliniques universitaires Saint-Luc
Brussels, Brussels Capital, 1200
About this study
Official title: Short-term Effects of SIMEOX on Static Hyperinflation in Patients With Chronic Obstructive Pulmonary Disease
This study will investigate the effects on the SIMEOX technology on static hyperinflation in patients with chronic obstructive pulmonary disease (COPD).
Read the detailed description
This is a crossover study assessing the short-term effects of SIMEOX and PEP device on static hyperinflation in patients with COPD.
Patients will perform lung function tests (to assess the residual volume and functional residual capacity) before, after and 30 minutes after a 20-min long session of SIMEOX or PEP (depending of randomization).
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- SIMEOX, PEP
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIMEOXDevice
SIMEOX is a device generating a succession of gentle depression at the mouth.
PEPDevice
A PEP device (Pari-PEP) will be used to provoke a positive expiratory pressure while exhaling, thereby stabilizing the airways during expiration.
| Study group | Role | What they receive |
|---|---|---|
| SIMEOX | Active comparator | Participants will have to perform 20 minutes of SIMEOX. Passive exhalation is required using the SIMEOX, starting from tidal volume and going until achieving residual volume. Receives: Device: SIMEOX |
| PEP | Active comparator | Participants will have to perform 20 minutes of PEP. Active exhalation is required using a PEP device, starting from tidal volume and going until achieving residual volume. Receives: Device: PEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional residual capacity (FRC) using body plethysmography
FRCpleth before, after and 30 minutes after performing SIMEOX and PEP will be compared.
Measured: 15 minutes
Change in functional residual capacity (FRC) using helium dilution
FRChe before, after and 30 minutes after performing SIMEOX and PEP will be compared.
Measured: 5 minutes
Change in air trapping
FRCpleth - FRChe before, after and 30 minutes after performing SIMEOX and PEP will be compared.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start5 Aug 2019
- Primary completion16 Mar 2021
- Study completion16 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The visits include sessions (test 1 and 2) with SIMEOX or a positive expiratory pressure device (PEP) (chosen according to the subject's randomization) lasting 20 minutes, each followed by a rest period of 30 minutes. Lung function tests will be performed before, after and 30 minutes after performing the devices (SIMEOX and PEP).
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Poncin, PT, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157972
- Sponsor's protocol ID
- SIMEOX-004
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2019
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Macedo JRFF, Aubriot AS, Reychler G, Penelle M, Gohy S, Poncin W. The intermittent intrapulmonary deflation technique for airway clearance in patients with cystic fibrosis: A randomized trial. Respir Med Res. 2024 Nov;86:101094. doi: 10.1016/j.resmer.2024.101094. Epub 2024 Feb 29.
PubMed 38843595Ribeiro Fonseca Franco de Macedo J, Reychler G, Poncin W, Liistro G. Effects of the intermittent intrapulmonary deflation technique on expiratory flow limitation: an in vitro study. J Clin Monit Comput. 2024 Feb;38(1):69-75. doi: 10.1007/s10877-023-01093-3. Epub 2023 Nov 2.
PubMed 37917211de Macedo JRFF, Reychler G, Liistro G, Poncin W. Short-Term Effect of Intermittent Intrapulmonary Deflation on Air Trapping in Patients With COPD. Respir Care. 2023 Apr;68(4):478-487. doi: 10.4187/respcare.10398. Epub 2023 Feb 21.
PubMed 36810360
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of SIMEOX on Static Hyperinflation in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04157972
- Acronym / sponsor ID
- SIMEOX-004
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 16 Mar 2021 (actual)
- Study completion
- 16 Mar 2021 (actual)
- First posted
- 8 Nov 2019 (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.
This study will investigate the effects on the SIMEOX technology on static hyperinflation in patients with chronic obstructive pulmonary disease (COPD).
Detailed description
This is a crossover study assessing the short-term effects of SIMEOX and PEP device on static hyperinflation in patients with COPD.
Patients will perform lung function tests (to assess the residual volume and functional residual capacity) before, after and 30 minutes after a 20-min long session of SIMEOX or PEP (depending of randomization).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The visits include sessions (test 1 and 2) with SIMEOX or a positive expiratory pressure device (PEP) (chosen according to the subject's randomization) lasting 20 minutes, each followed by a rest period of 30 minutes. Lung function tests will be performed before, after and 30 minutes after performing the devices (SIMEOX and PEP).
| Arm | Type | Receives |
|---|---|---|
| SIMEOX | Active comparator | Device: SIMEOXParticipants will have to perform 20 minutes of SIMEOX. Passive exhalation is required using the SIMEOX, starting from tidal volume and going until achieving residual volume. |
| PEP | Active comparator | Device: PEPParticipants will have to perform 20 minutes of PEP. Active exhalation is required using a PEP device, starting from tidal volume and going until achieving residual volume. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with chronic obstructive pulmonary disease,
- Forced expiratory volume in 1s (FEV1) <80% of predicted value,
- Stable condition (no pulmonary exacerbation for more than 28 days).
Key exclusion criteria (5 listed)
- Routine use of one of the two treatments - SIMEOX and/or PEP,
- Inability to understand or carry out the instructions,
- Severe cardiac comorbidity, neuromuscular disease,
- Severe scoliosis,
- Patient with a pacemaker.
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 |
|---|---|---|
| SIMEOXSIMEOX is a device generating a succession of gentle depression at the mouth. | Device | SIMEOX |
| PEPA PEP device (Pari-PEP) will be used to provoke a positive expiratory pressure while exhaling, thereby stabilizing the airways during expiration. | Device | PEP |
Primary outcome
Change in functional residual capacity (FRC) using body plethysmography
Time frame: 15 minutes
FRCpleth before, after and 30 minutes after performing SIMEOX and PEP will be compared.
Change in functional residual capacity (FRC) using helium dilution
Time frame: 5 minutes
FRChe before, after and 30 minutes after performing SIMEOX and PEP will be compared.
Change in air trapping
Time frame: 20 minutes
FRCpleth - FRChe before, after and 30 minutes after performing SIMEOX and PEP will be compared.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Derived from this study: PubMed 38843595de Macedo JRFF, Aubriot AS, Reychler G, Penelle M, Gohy S, Poncin W. The intermittent intrapulmonary deflation technique for airway clearance in patients with cystic fibrosis: A randomized trial. Respir Med Res. 2024 Nov;86:101094. doi: 10.1016/j.resmer.2024.101094. Epub 2024 Feb 29.
- Derived from this study: PubMed 37917211Ribeiro Fonseca Franco de Macedo J, Reychler G, Poncin W, Liistro G. Effects of the intermittent intrapulmonary deflation technique on expiratory flow limitation: an in vitro study. J Clin Monit Comput. 2024 Feb;38(1):69-75. doi: 10.1007/s10877-023-01093-3. Epub 2023 Nov 2.
- Derived from this study: PubMed 36810360de Macedo JRFF, Reychler G, Liistro G, Poncin W. Short-Term Effect of Intermittent Intrapulmonary Deflation on Air Trapping in Patients With COPD. Respir Care. 2023 Apr;68(4):478-487. doi: 10.4187/respcare.10398. Epub 2023 Feb 21.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Disease, Chronic Obstructive
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIMEOX and PEP in people with Pulmonary Disease, Chronic Obstructive, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in functional residual capacity (FRC) using body plethysmography (time frame: 15 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04157972, which also lists 3 linked publications.
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 21 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.