Effects of SIMEOX on Flow and Volume in Healthy Subjects and 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 flow and volume generated in healthy subjects and patients with COPD

Detailed Description
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This is a crossover study assessing the immediate physiological effects of SIMEOX and a PEP device on the exhalation phase in healthy subjects and patients with COPD. Participants will perform (1) a slow vital capacity, (2) a maximal expiration from total lung capacity to residual volume with SIMEOX, (3) a maximal expiration from total lung capacity to residual volume with a PEP device.

Official Title
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Evaluation of SIMEOX Technology on Volumes and Flows Generated in Healthy Subjects and Patients With COPD

Conditions
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Healthy, Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Device: SIMEOX
* Device: PEP
* Other: Spontaneous Exhalation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects: able to understand the instructions, no acute or chronic respiratory upper or lower airway disease, normal lung function. Patients with COPD: able to understand the instructions; FEV1<80% predicted value, naive to the SIMEOX device. Exclusion Criteria: Healthy subjects: obesity (BMI > 30kg/m²); active or former smoker; severe scoliosis; cardiovascular or neuromuscular disease. Patients with COPD: obesity (BMI > 30kg/m²); severe scoliosis; cardiovascular or neuromuscular disease.

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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Accepts Healthy Volunteers

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spontaneous slow vital capacity<br>Participants will have to perform a slow vital capacity according to the guidelines, from total lung capacity to residual volume | Other: Spontaneous Exhalation<br>* A slow vital capacity maneuver will be performed according to the guidelines, from total lung capacity to residual volume<br>|
| Active Comparator: SIMEOX<br>Participants will have to perform a passive exhalation using the SIMEOX, starting from total lung capacity 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 an active exhalation using a PEP device, starting from total lung capacity 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 expiratory volume | Expiratory volume change between the 3 conditions (spontaneous expiration, SIMEOX and PEP). | 5 minutes | 
| Change in expiratory flow | Expiratory flow change between the 3 conditions (spontaneous expiration, SIMEOX and PEP). | 5 minutes |