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

NCT04150601 | Completed

• 1 other identifier: SIMEOX-002
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy; Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

• Change in expiratory volume

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

  5 minutes

• Change in expiratory flow

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

  5 minutes

Study Arms (3)

Spontaneous slow vital capacity

ACTIVE COMPARATOR

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

Other: Spontaneous Exhalation

SIMEOX

ACTIVE COMPARATOR

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

Device: SIMEOX

PEP

ACTIVE COMPARATOR

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

Interventions

SIMEOX DEVICE

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

SIMEOX

PEP DEVICE

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

PEP

Spontaneous Exhalation OTHER

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

Spontaneous slow vital capacity

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, Brussels Capital, 1200, Belgium

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 5, 2019
• Study Start: August 1, 2019
• Primary Completion: November 16, 2021
• Study Completion: November 16, 2021
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)