Intermittent Intrapulmonary Deflation and Dyspnea Following Exercise in People With Chronic Obstructive Pulmonary Disease

NANot yet recruitingINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

June 1, 2025

Primary Completion Date

February 28, 2028

Study Completion Date

February 28, 2028

Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
DEVICE

Active intermittent intrapulmonary deflation.

"Intermittent intrapulmonary deflation sessions will be performed using the SIMEOX device (SIMEOX, PhysioAssist, Aix-en-Provence, France), which will be delivered to the patient's home by a home healthcare provider. The device power setting (25%, 50%, 75%, or 100%) will be individualized according to the parameters determined during the familiarization visit by a trained physiotherapist. Patients will be instructed to perform tidal volume inspirations followed by passive expirations into the device through a mouthpiece, up to their maximal tolerance. The device will be activated by the patient during expiration using a manual remote control.~Each device usage cycle consists of 10 expirations, with oscillations generated at 12 Hz during the first 8 cycles and at 6 Hz during the last 2 cycles. Rest periods will be allowed during the session, and a mandatory pause will be imposed every 10 expirations. The session duration is fixed at 20 minutes, with patients performing one session in the"

DEVICE

Placebo intermittent intrapulmonary deflation.

"Placebo intermittent intrapulmonary deflation sessions will be performed using the SIMEOX device (SIMEOX, PhysioAssist, Aix-en-Provence, France), which will be delivered to the patient's home by a home healthcare provider. Due to the physiological mechanism of action of the device (intermittent negative pressure with increasing intensity, inversely proportional to airflow resistance), it is assumed that device use under placebo conditions will be infra-therapeutic.~To ensure this, the device will be set to the same setting as the active intermittent intrapulmonary deflation session but an intentional air leak will be introduced into the circuit at the device's output (not visible to the participant) to prevent the generated negative pressure from exceeding t The validity of this placebo condition will be confirmed through bench tests.~All other conditions will remain identical to the active intermittent intrapulmonary deflation sessions. Patients will be instructed to perform tidal vo"

Trial Locations (1)

76000

ADIR Association, Rouen

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

PhysioAssist

UNKNOWN

lead

ADIR Association

OTHER

NCT06956742 - Intermittent Intrapulmonary Deflation and Dyspnea Following Exercise in People With Chronic Obstructive Pulmonary Disease | Biotech Hunter | Biotech Hunter