Wearable Noninvasive Positive Pressure Ventilation Device in 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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-12

Study Completion Date

2018-01-10

Brief Summary

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

The objective is to assess the impact of a wearable Noninvasive Positive Pressure Ventilation, on physical activity and quality of life in patients with severe COPD, complaining of dyspnea.

Related Clinical Trials

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

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

NCT06956742

Chronic Obstructive Pulmonary Disease (COPD)

RECRUITING NA

Oxygen Therapy Remote Monitoring in COPD Patients.

NCT05473780

Chronic Obstructive Pulmonary Disease

ACTIVE_NOT_RECRUITING

The Use of Medical Devices to Monitor Chronic Obstructive Pulmonary Disease Patients Study BREATH-TRACHER 1

NCT06419036

COPD Exacerbation Acute

ENROLLING_BY_INVITATION

Interfaces of Non-invasive Ventilation on Performance in Patients With Chronic Obstructive Pulmonary Disease

NCT02796599

Chronic Obstructive Pulmonary Disease Non Invasive Ventilation Exercise, Aerobic

COMPLETED NA

Early Warning Value of Consumer Wearable Devices in AECOPD

NCT05974670

COPD

UNKNOWN

Detailed Description

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

In order to avoid the occurrence of uncomfortable dyspnea, patients with Chronic Obstructive Pulmonary Disease (COPD) are locked in a vicious circle of inactivity and social isolation which profoundly affects their quality of life and prognosis. A new wearable non invasive positive pressure ventilation device has been recently proposed; it can be used by intermittence during or after physical activities for reducing dyspnea or for shortening dyspnea- recovery time. The investigators hypothesize that this system, in reducing the inconvenience caused by dyspnea, would stimulate a more active lifestyle and improve quality of life. Their objective is to assess the impact of this device on physical activity and quality of life in patients with severe COPD, complaining of dyspnea.

In this open study with no control group, participants will use the device at their convenience, according to their needs in daily life and for 4 weeks.

Conditions

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

Non-Invasive Ventilation

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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

Noninvasive ventilation

Participants will use the device at home by intermittence during or after physical activities for reducing dyspnea or for shortening dyspnea-recovery time over a 4-week period.

Group Type EXPERIMENTAL

Non-Invasive Ventilation

Intervention Type DEVICE

Interventions

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

Non-Invasive Ventilation

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 stable severe COPD (with FEV1 ≤50% predicted)
* Patients with mMRC score \> ou = 2.

Exclusion Criteria

* Exacerbate within a month prior.
* Using other non invasive ventilation device \> 15h per day.
* Have musculoskeletal or neuromuscular problem affecting balance and walking.
* Have cognitive problem affecting comprehension of the different évaluations or questionnaires.
* Have recently participated in physical training or rehabilitation program (≤ 3 months).
* Medical contra-indication to NIV.
* Evolutionary pathologies (excluding COPD) may be life-threatening in the short term (1 year) (cancer, neuromuscular disease rapidly changing).
* Simultaneously enrolled in an other clinical trial.
* Not affiliated to social security.
* Person deprived of liberty, major protected by law.

Minimum Eligible Age

35 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No