Effects of SIMEOX on Flow and Volume in Healthy Subjects and Patients With COPD

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

Evaluation of SIMEOX Technology on Volumes and Flows Generated in Healthy Subjects and Patients With COPD

This study will investigate the effects on the SIMEOX technology on flow and volume generated in healthy subjects and patients with COPD

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a crossover study assessing the immediate physiological effects of SIMEOX and a PEP device on the exhalation phase in healthy subjects and patients with COPD.

Participants will perform (1) a slow vital capacity, (2) a maximal expiration from total lung capacity to residual volume with SIMEOX, (3) a maximal expiration from total lung capacity to residual volume with a PEP device.

Study Type

Interventional

Enrollment (Actual)

48

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

Yes

Description

Inclusion Criteria:

  • Healthy subjects: able to understand the instructions, no acute or chronic respiratory upper or lower airway disease, normal lung function.
  • Patients with COPD: able to understand the instructions; FEV1<80% predicted value, naive to the SIMEOX device.

Exclusion Criteria:

  • Healthy subjects: obesity (BMI > 30kg/m²); active or former smoker; severe scoliosis; cardiovascular or neuromuscular disease.
  • Patients with COPD: obesity (BMI > 30kg/m²); severe scoliosis; cardiovascular or neuromuscular disease.

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: Spontaneous slow vital capacity
Participants will have to perform a slow vital capacity according to the guidelines, from total lung capacity to residual volume
Other: Spontaneous Exhalation
A slow vital capacity maneuver will be performed according to the guidelines, from total lung capacity to residual volume
Active Comparator: SIMEOX
Participants will have to perform a passive exhalation using the SIMEOX, starting from total lung capacity 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 an active exhalation using a PEP device, starting from total lung capacity 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 expiratory volume
Time Frame: 5 minutes
Expiratory volume change between the 3 conditions (spontaneous expiration, SIMEOX and PEP).
5 minutes
Change in expiratory flow
Time Frame: 5 minutes
Expiratory flow change between the 3 conditions (spontaneous expiration, SIMEOX and PEP).
5 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 1, 2019

Primary Completion (Actual)

November 16, 2021

Study Completion (Actual)

November 16, 2021

Study Registration Dates

First Submitted

October 31, 2019

First Submitted That Met QC Criteria

October 31, 2019

First Posted (Actual)

November 5, 2019

Study Record Updates

Last Update Posted (Actual)

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-002

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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