Effects of SIMEOX on Static Hyperinflation in Patients With COPD
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|ClinicalTrials.gov Identifier: NCT04157972|
Recruitment Status : Unknown
Verified November 2020 by Poncin, Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was: Recruiting
First Posted : November 8, 2019
Last Update Posted : November 3, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive||Device: SIMEOX Device: PEP||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Crossover Assignment|
|Intervention 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)|
|Official Title:||Short-term Effects of SIMEOX on Static Hyperinflation in Patients With Chronic Obstructive Pulmonary Disease|
|Actual Study Start Date :||August 5, 2019|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2021|
Active Comparator: SIMEOX
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.
SIMEOX is a device generating a succession of gentle depression at the mouth.
Active Comparator: PEP
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.
A PEP device (Pari-PEP) will be used to provoke a positive expiratory pressure while exhaling, thereby stabilizing the airways during expiration.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||45 Years to 90 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04157972
|Contact: William Poncin, PT, PhDemail@example.com|
|Contact: Juliana RFF de Macedo, PT, MScfirstname.lastname@example.org|
|Cliniques universitaires Saint-Luc||Recruiting|
|Brussels, Brussels Capital, Belgium, 1200|
|Contact: William Poncin +320470592032 ext +320470592032 email@example.com|
|Responsible Party:||Poncin, Principal Investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain|
|Other Study ID Numbers:||
|First Posted:||November 8, 2019 Key Record Dates|
|Last Update Posted:||November 3, 2020|
|Last Verified:||November 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive