Effects of SIMEOX on Static Hyperinflation in Patients With COPD

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

Detailed Description
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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).

Official Title
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Short-term Effects of SIMEOX on Static Hyperinflation in Patients With Chronic Obstructive Pulmonary Disease

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Device: SIMEOX
* Device: PEP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SIMEOX<br>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<br>* SIMEOX is a device generating a succession of gentle depression at the mouth.<br>|
| Active Comparator: PEP<br>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<br>* A PEP device (Pari-PEP) will be used to provoke a positive expiratory pressure while exhaling, thereby stabilizing the airways during expiration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in functional residual capacity (FRC) using body plethysmography | FRCpleth before, after and 30 minutes after performing SIMEOX and PEP will be compared. | 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. | 5 minutes | 
| Change in air trapping | FRCpleth - FRChe before, after and 30 minutes after performing SIMEOX and PEP will be compared. | 20 minutes |