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

Primary Purpose

Healthy, Pulmonary Disease, Chronic Obstructive

Status

Unknown status

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

SIMEOX

PEP

Spontaneous Exhalation

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

45 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Cliniques universitaires Saint-LucRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Spontaneous slow vital capacity

SIMEOX

PEP

Arm Description

Participants will have to perform a slow vital capacity according to the guidelines, from total lung capacity to residual volume

Participants will have to perform a passive exhalation using the SIMEOX, starting from total lung capacity and going until achieving residual volume

Participants will have to perform an active exhalation using a PEP device, starting from total lung capacity and going until achieving residual volume

Outcomes

Primary Outcome Measures

Change in expiratory volume

Expiratory volume change between the 3 conditions (spontaneous expiration, SIMEOX and PEP).

Change in expiratory flow

Expiratory flow change between the 3 conditions (spontaneous expiration, SIMEOX and PEP).

Secondary Outcome Measures

Full Information

NCT ID

NCT04150601

First Posted

October 31, 2019

Last Updated

November 1, 2020

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

1. Study Identification

Unique Protocol Identification Number

NCT04150601

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2019 (Actual)

Primary Completion Date

November 2021 (Anticipated)

Study Completion Date

November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Spontaneous slow vital capacity

Arm Type

Active Comparator

Arm Description

Participants will have to perform a slow vital capacity according to the guidelines, from total lung capacity to residual volume

Arm Title

SIMEOX

Arm Type

Active Comparator

Arm Description

Participants will have to perform a passive exhalation using the SIMEOX, starting from total lung capacity and going until achieving residual volume

Arm Title

PEP

Arm Type

Active Comparator

Arm Description

Participants will have to perform an active exhalation using a PEP device, starting from total lung capacity and going until achieving residual volume

Intervention Type

Device

Intervention Name(s)

SIMEOX

Intervention Description

SIMEOX is a device generating a succession of gentle depression at the mouth.

Intervention Type

Device

Intervention Name(s)

PEP

Intervention Description

A PEP device (Pari-PEP) will be used to provoke a positive expiratory pressure while exhaling, thereby stabilizing the airways during expiration.

Intervention Type

Other

Intervention Name(s)

Spontaneous Exhalation

Intervention Description

A slow vital capacity maneuver will be performed according to the guidelines, from total lung capacity to residual volume

Primary Outcome Measure Information:

Title

Change in expiratory volume

Description

Expiratory volume change between the 3 conditions (spontaneous expiration, SIMEOX and PEP).

Time Frame

5 minutes

Title

Change in expiratory flow

Description

Expiratory flow change between the 3 conditions (spontaneous expiration, SIMEOX and PEP).

Time Frame

5 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

William Poncin, PT, PhD

Phone

+3227642316

william.poncin@uclouvain.be

First Name & Middle Initial & Last Name or Official Title & Degree

Juliana RFF de Macedo, PT, MSc

juliana.ribeiro@uclouvain.be

Facility Information:

Facility Name

Cliniques universitaires Saint-Luc

City

Brussels

State/Province

Brussels Capital

ZIP/Postal Code

1200

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

William Poncin

Phone

+320470592032

Ext

+320470592032

william.poncin@uclouvain.be

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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