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Completed

NCT Number: NCT04150601

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

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

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Key information

Conditions

Healthy Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

45 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques universitaires Saint-Luc

Brussels, Brussels Capital, 1200, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Simeox

Device

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

PEP

Device

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

Spontaneous Exhalation

Other

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

Primary outcomes

  1. Change in expiratory volume

    Time frame: 5 minutes

    Expiratory volume change between the 3 conditions (spontaneous expiration, SIMEOX and PEP).

  2. Change in expiratory flow

    Time frame: 5 minutes

    Expiratory flow change between the 3 conditions (spontaneous expiration, SIMEOX and PEP).

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 5, 2019
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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