Effects of SIMEOX on Flow and Volume

November 22, 2023 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Evaluation of SIMEOX on Flow and Volume Elicited in Healthy Subjects

This study will investigate the effects of the SIMEOX (an airway clearance device) on flow and volume generated in healthy subjects

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This is a pilot study assessing the effect of the SIMEOX device on flow and volume generated in healthy subjects.

Assessment of flow and volume will be performed before and during the application of the SIMEOX. Vital capacity and expiratory flow will be assessed.

Study Type

Interventional

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, Belgium, 1200
        • William Poncin

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Able to understand the instructions

Exclusion Criteria:

  • Obesity (BMI > 30kg/m²)
  • Active smoker
  • Severe scoliosis
  • Cardiovascular ou 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SIMEOX
Use of the device SIMEOX to exhale
Device: SIMEOX
SIMEOX is a device generating a succession of gentle depression at the mouth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in expiratory volume
Time Frame: 5min
Expiratory volume before and during the use of the SIMEOX will be compared
5min
Change in expiratory volume flow rate
Time Frame: 5min
Expiratory flow rate before and during the use of the SIMEOX will be compared
5min

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

Investigators

  • Principal Investigator: Grégory Reychler, PhD, Cliniques Universitaires Saint-luc

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)

September 15, 2018

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

August 28, 2018

First Submitted That Met QC Criteria

August 30, 2018

First Posted (Actual)

August 31, 2018

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 22, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • SIMEOX-01
  • 2018/08AOU/312 (Other Identifier: CEHF)

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.

Clinical Trials on Healthy

Clinical Trials on SIMEOX

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe