Effects of SIMEOX on Flow and Volume in Healthy Subjects and Patients With COPD

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04150601

Enrollment

Registered

2019-11-05

Start date

2019-08-01

Completion date

2021-11-16

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

Healthy, Pulmonary Disease, Chronic Obstructive

Brief summary

This study will investigate the effects on the SIMEOX technology on flow and volume generated in healthy subjects and patients with COPD

Detailed description

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.

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.

OTHERSpontaneous Exhalation

A slow vital capacity maneuver will be performed according to the guidelines, from total lung capacity to residual volume

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

45 Years to 90 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in expiratory volume	5 minutes	Expiratory volume change between the 3 conditions (spontaneous expiration, SIMEOX and PEP).
Change in expiratory flow	5 minutes	Expiratory flow change between the 3 conditions (spontaneous expiration, SIMEOX and PEP).

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026