Effects of SIMEOX on Static Hyperinflation in Patients With COPD

Overview

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

Full Title of Study: “Short-term Effects of SIMEOX on Static Hyperinflation in Patients With Chronic Obstructive Pulmonary Diseases”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2020

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).

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: 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.
  • Active Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.
  • Change in air trapping
    • Time Frame: 20 minutes
    • FRCpleth – FRChe before, after and 30 minutes after performing SIMEOX and PEP will be compared.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with chronic obstructive pulmonary diseases
  • 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.

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  • Provider of Information About this Clinical Study
    • Principal Investigator: Poncin, Principal Investigator – Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  • Overall Contact(s)
    • William Poncin, PT, PhD, +3227642316, william.poncin@uclouvain.be

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