Clinical trial NCT03130361: Wearable Noninvasive Positive Pressure Ventilation Device in COPD
Official title: Evaluation of the Impact of a Wearable Noninvasive Positive Pressure Ventilation Device on Physical Activity and Quality of Life in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Invasive Ventilation
Lead sponsor: Icadom
Sponsor class: INDUSTRY
Collaborators: name: Philips Respironics
First posted: 2017-04-26
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of daily physical activity measured by actimetry
timeFrame: Continuously over a 8-week period (2 weeks before the use of the device, over the 4-week period usinf the device and 2 weeks after the use of the device
Secondary outcomes:
measure: Change of Baseline Dyspnea Index (BDI) score
timeFrame: baseline and post use of the Vitabreath device at 4th weeks
measure: Change of Modified Medical Research Council Questionnaire (mMRC) score
timeFrame: baseline and post use of the Vitabreath device at 4th weeks
measure: Change of Transition Dyspnea Index (TDI)
timeFrame: baseline and post use of the Vitabreath device at 4th weeks
measure: Subjective appréciation of the device
timeFrame: post use of the Vitabreath device at 4th weeks
measure: Change of Visual Simplified Respiratory Questionnaire (VSRQ) score
timeFrame: baseline and post use of the Vitabreath device at 4th weeks
measure: Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT)score
timeFrame: Continuously over a 8-week period (2 weeks before the use of the device, over the 4-week period usinf the device and 2 weeks after the use of the device
Other outcomes:
measure: Compliance to the device
timeFrame: Every week over the 4-week period
measure: Number of acute exacerbation
timeFrame: Up to 12 months before the date of inclusion
measure: Weight
timeFrame: baseline and post use of the Vitabreath device at 4th weeks
Locations:
city: Alès
country: France
facility: Dr Michèle Bognie Pneumology Office
city: Castelnau-le-Lez
country: France
facility: Clinique du Parc
city: Grenoble
country: France
facility: CHU Grenoble-Alpes
city: Lille
country: France
facility: Hôpital Privé La Louvière
city: Lunel
country: France
facility: Dr Christian PAILLARGUELO Pneumology Office
city: Nîmes
country: France
facility: CHU Caremeau
city: Toulouse
country: France
facility: Clinique Pasteur
Study officials:
affiliation: Laboratoire du sommeil - Centre hospitalier Universitaire Michallon - 38043 GRENOBLE
name: Jean-Louis PEPIN, Pr
role: PRINCIPAL_INVESTIGATOR
References: