Effects of SIMEOX on Static Hyperinflation in Patients With COPD

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Device: PEP; Device: SIMEOX

Study type: Interventional

Funder types: Other

Identifiers

NCT04157972

SIMEOX-004

Details and patient eligibility

About

This study will investigate the effects on the SIMEOX technology on static hyperinflation in patients with chronic obstructive pulmonary disease (COPD).

Full description

This is a crossover study assessing the short-term effects of SIMEOX and PEP device on static hyperinflation in patients with COPD.

Patients will perform lung function tests (to assess the residual volume and functional residual capacity) before, after and 30 minutes after a 20-min long session of SIMEOX or PEP (depending of randomization).

Enrollment: 25 patients

Sex: All

Ages: 45 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with chronic obstructive pulmonary disease,
• Forced expiratory volume in 1s (FEV1) <80% of predicted value,
• Stable condition (no pulmonary exacerbation for more than 28 days).

Exclusion criteria

• Routine use of one of the two treatments - SIMEOX and/or PEP,
• Inability to understand or carry out the instructions,
• Severe cardiac comorbidity, neuromuscular disease,
• Severe scoliosis,
• Patient with a pacemaker.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

SIMEOX

Active Comparator group

Description:

Participants will have to perform 20 minutes of SIMEOX. Passive exhalation is required using the SIMEOX, starting from tidal volume and going until achieving residual volume.

Treatment:

Device: SIMEOX

PEP

Active Comparator group

Description:

Participants will have to perform 20 minutes of PEP. Active exhalation is required using a PEP device, starting from tidal volume and going until achieving residual volume.

Treatment:

Device: PEP