Effects of SIMEOX on Static Hyperinflation in Patients With COPD

Not Applicable

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Device: PEP; Device: SIMEOX

• Registration Number: NCT04157972
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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).

Study Timeline

• Study Start: 2019-08-05
• Study First Submitted: 2019-11-06
• Study First Submitted QC: 2019-11-07
• Study First Posted: 2019-11-08
• Primary Completion: 2021-03-16
• Study Completion: 2021-03-16
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-18
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PEP	PEP	Participants will have to perform 20 minutes of PEP. Active exhalation is required using a PEP device, starting from tidal volume and going until achieving residual volume.
SIMEOX	SIMEOX	Participants will have to perform 20 minutes of SIMEOX. Passive exhalation is required using the SIMEOX, starting from tidal volume and going until achieving residual volume.

Primary Outcome Measures

Name	Time	Method
Change in air trapping	20 minutes	FRCpleth - FRChe before, after and 30 minutes after performing SIMEOX and PEP will be compared.
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.

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Brussels, Brussels Capital, Belgium