Effects of SIMEOX on Static Hyperinflation in Patients With COPD

November 18, 2023 updated by: William Poncin, PT, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Brussels Capital
      • Brussels, Brussels Capital, Belgium, 1200
        • Cliniques Universitaires Saint-Luc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 minutes
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.
5 minutes
Change in air trapping
Time Frame: 20 minutes
FRCpleth - FRChe before, after and 30 minutes after performing SIMEOX and PEP will be compared.
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2019

Primary Completion (Actual)

March 16, 2021

Study Completion (Actual)

March 16, 2021

Study Registration Dates

First Submitted

November 6, 2019

First Submitted That Met QC Criteria

November 7, 2019

First Posted (Actual)

November 8, 2019

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 18, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIMEOX-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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