Wearable Noninvasive Positive Pressure Ventilation Device in COPD (VITABREATH)

ICADOM Medical Center

Status: Completed

Conditions: Non-Invasive Ventilation

Treatments: Device: Non-Invasive Ventilation

Study type: Interventional

Funder types: Industry

Identifiers

NCT03130361

2016-A01297-44

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 35 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Noninvasive ventilation

Experimental group

Description:

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.

Treatment:

Device: Non-Invasive Ventilation