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Effects of SIMEOX on Static Hyperinflation in Patients With COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Poncin, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Description
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Brief Summary:
This study will investigate the effects on the SIMEOX technology on static hyperinflation in patients with chronic obstructive pulmonary disease (COPD).

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Device: SIMEOX Device: PEP Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arms and Interventions
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Arm Intervention/treatment
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.
 Device: SIMEOX
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.
 Device: PEP
A PEP device (Pari-PEP) will be used to provoke a positive expiratory pressure while exhaling, thereby stabilizing the airways during expiration.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Change in air trapping [ Time Frame: 20 minutes ]
    FRCpleth - FRChe before, after and 30 minutes after performing SIMEOX and PEP will be compared.


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: William Poncin, PT, PhD +3227642316 william.poncin@uclouvain.be
Contact: Juliana RFF de Macedo, PT, MSc juliana.ribeiro@uclouvain.be

Locations
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Belgium
Cliniques universitaires Saint-Luc Recruiting
Brussels, Brussels Capital, Belgium, 1200
Contact: William Poncin    +320470592032 ext +320470592032    william.poncin@uclouvain.be   
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
More Information
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Responsible Party: Poncin, Principal Investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT04157972    
Other Study ID Numbers: SIMEOX-004
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Chronic Disease
 Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive