Effects of SIMEOX on Static Hyperinflation in Patients With COPD

Cliniques universitaires Saint-Luc- Université Catholique de Louvain25 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

SIMEOXDEVICE

SIMEOX is a device generating a succession of gentle depression at the mouth.

PEPDEVICE

A PEP device (Pari-PEP) will be used to provoke a positive expiratory pressure while exhaling, thereby stabilizing the airways during expiration.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cliniques universitaires Saint-Luc

Brussels, Brussels Capital, Belgium

Outcomes

Primary Outcomes

Change in functional residual capacity (FRC) using body plethysmography

FRCpleth before, after and 30 minutes after performing SIMEOX and PEP will be compared.

Time frame: 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.

Time frame: 5 minutes

Change in air trapping

FRCpleth - FRChe before, after and 30 minutes after performing SIMEOX and PEP will be compared.

Time frame: 20 minutes

Data from ClinicalTrials.gov

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