Effects of SIMEOX on Static Hyperinflation in Patients With COPD

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04157972

Enrollment

Registered

2019-11-08

Start date

2019-08-05

Completion date

2021-03-16

Last updated

2023-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

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).

Interventions

DEVICESIMEOX

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

DEVICEPEP

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

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).

Eligibility

Sex/Gender

ALL

Age

45 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in functional residual capacity (FRC) using body plethysmography	15 minutes	FRCpleth before, after and 30 minutes after performing SIMEOX and PEP will be compared.
Change in functional residual capacity (FRC) using helium dilution	5 minutes	FRChe before, after and 30 minutes after performing SIMEOX and PEP will be compared.
Change in air trapping	20 minutes	FRCpleth - FRChe before, after and 30 minutes after performing SIMEOX and PEP will be compared.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026