Effects of SIMEOX on Static Hyperinflation in Patients With COPD
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
SIMEOX
PEP
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility 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.
Sites / Locations
- Cliniques universitaires Saint-LucRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
SIMEOX
PEP
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in functional residual capacity (FRC) using body plethysmography
FRCpleth before, after and 30 minutes after performing SIMEOX and PEP will be compared.
Change in functional residual capacity (FRC) using helium dilution
FRChe before, after and 30 minutes after performing SIMEOX and PEP will be compared.
Change in air trapping
FRCpleth - FRChe before, after and 30 minutes after performing SIMEOX and PEP will be compared.
Secondary Outcome Measures
Full Information
NCT ID
NCT04157972
First Posted
November 6, 2019
Last Updated
November 1, 2020
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT04157972
Brief Title
Effects of SIMEOX on Static Hyperinflation in Patients With COPD
Official Title
Short-term Effects of SIMEOX on Static Hyperinflation in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 5, 2019 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SIMEOX
Arm Type
Active Comparator
Arm Description
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.
Arm Title
PEP
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SIMEOX
Intervention Description
SIMEOX is a device generating a succession of gentle depression at the mouth.
Intervention Type
Device
Intervention Name(s)
PEP
Intervention Description
A PEP device (Pari-PEP) will be used to provoke a positive expiratory pressure while exhaling, thereby stabilizing the airways during expiration.
Primary Outcome Measure Information:
Title
Change in functional residual capacity (FRC) using body plethysmography
Description
FRCpleth before, after and 30 minutes after performing SIMEOX and PEP will be compared.
Time Frame
15 minutes
Title
Change in functional residual capacity (FRC) using helium dilution
Description
FRChe before, after and 30 minutes after performing SIMEOX and PEP will be compared.
Time Frame
5 minutes
Title
Change in air trapping
Description
FRCpleth - FRChe before, after and 30 minutes after performing SIMEOX and PEP will be compared.
Time Frame
20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
William Poncin, PT, PhD
Phone
+3227642316
Email
william.poncin@uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
Juliana RFF de Macedo, PT, MSc
Email
juliana.ribeiro@uclouvain.be
Facility Information:
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
State/Province
Brussels Capital
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Poncin
Phone
+320470592032
Ext
+320470592032
Email
william.poncin@uclouvain.be
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of SIMEOX on Static Hyperinflation in Patients With COPD
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