Effects of SIMEOX on Static Hyperinflation in Patients With COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-05

Study Completion Date

2021-03-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT04150601

Healthy Pulmonary Disease, Chronic Obstructive

COMPLETED NA

Symptom-driven Maintenance and Reliever Treatment to Prevent Exacerbations in COPD

NCT02477397

COPD

UNKNOWN PHASE3

Study to Assess the Effect of Formoterol and Beclomethasone Dipropionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01204034

Chronic Obstructive Pulmonary Disease

COMPLETED PHASE3

IMD-1041 Chronic Obstructive Pulmonary Disease: Proof of Concept (POC) Study

NCT00883584

Chronic Obstructive Pulmonary Disease

UNKNOWN PHASE2

Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients.

NCT00783406

Pulmonary Disease, Chronic Obstructive

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease, Chronic Obstructive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The visits include sessions (test 1 and 2) with SIMEOX or a positive expiratory pressure device (PEP) (chosen according to the subject's randomization) lasting 20 minutes, each followed by a rest period of 30 minutes.

Lung function tests will be performed before, after and 30 minutes after performing the devices (SIMEOX and PEP).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SIMEOX

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.

Group Type ACTIVE_COMPARATOR

SIMEOX

Intervention Type DEVICE

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

PEP

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.

Group Type ACTIVE_COMPARATOR

PEP

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SIMEOX

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

Intervention Type DEVICE

PEP

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No