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

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)

Overall Status

Recruiting

CT.gov ID

NCT04150601

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Pulmonary Disease, Chronic Obstructive	Device: SIMEOX Device: PEP Other: Spontaneous Exhalation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2019

Anticipated Primary Completion Date :

Nov 1, 2021

Anticipated Study Completion Date :

Nov 1, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in expiratory volume [5 minutes]
Expiratory volume change between the 3 conditions (spontaneous expiration, SIMEOX and PEP).
Change in expiratory flow [5 minutes]
Expiratory flow change between the 3 conditions (spontaneous expiration, SIMEOX and PEP).

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cliniques universitaires Saint-Luc	Brussels	Brussels Capital	Belgium	1200

Sponsors and Collaborators

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Poncin, Principal Investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

ClinicalTrials.gov Identifier:

NCT04150601

Other Study ID Numbers:

SIMEOX-002

First Posted:

Nov 5, 2019

Last Update Posted:

Nov 3, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Nov 3, 2020