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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Completed

Conditions: Healthy; Pulmonary Disease, Chronic Obstructive

Treatments: Device: SIMEOX; Device: PEP; Other: Spontaneous Exhalation

Study type: Interventional

Funder types: Other

Identifiers

NCT04150601

SIMEOX-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 45 to 90 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 3 patient groups

Spontaneous slow vital capacity

Active Comparator group

Description:

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

Treatment:

Other: Spontaneous Exhalation

SIMEOX

Active Comparator group

Description:

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

Treatment:

Device: SIMEOX

PEP

Active Comparator group

Description:

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

Treatment:

Device: PEP