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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04150601
• Other study ID #: SIMEOX-002
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: November 16, 2021

Study information

• Verified date: November 2023
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 16, 2021
• Est. primary completion date: November 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Other:
• Spontaneous Exhalation
A slow vital capacity maneuver will be performed according to the guidelines, from total lung capacity to residual volume

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels	Brussels Capital

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in expiratory volume	Expiratory volume change between the 3 conditions (spontaneous expiration, SIMEOX and PEP).	5 minutes
Primary	Change in expiratory flow	Expiratory flow change between the 3 conditions (spontaneous expiration, SIMEOX and PEP).	5 minutes