Effects of SIMEOX on Static Hyperinflation in Patients With COPD

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04157972
• Other study ID #: SIMEOX-004
• Status: Completed
• Phase: N/A
• Start date: August 5, 2019
• Est. completion date: March 16, 2021

Study information

• Verified date: November 2023
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 16, 2021
• Est. primary completion date: March 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• SIMEOX
SIMEOX is a device generating a succession of gentle depression at the mouth.
• PEP
A PEP device (Pari-PEP) will be used to provoke a positive expiratory pressure while exhaling, thereby stabilizing the airways during expiration.

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels	Brussels Capital

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

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