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Completed

NCT Number: NCT04157972

Effects of SIMEOX on Static Hyperinflation in Patients With COPD

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

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms 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 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).

Who can participate

Healthy volunteers accepted: No

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

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.

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.

Primary outcomes

  1. Change in functional residual capacity (FRC) using body plethysmography

    Time frame: 15 minutes

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

  2. Change in functional residual capacity (FRC) using helium dilution

    Time frame: 5 minutes

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

  3. Change in air trapping

    Time frame: 20 minutes

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

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 8, 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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