Non-Invasive Ventilation
Conditions
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.
Interventions
DEVICENon-Invasive Ventilation
Sponsors
Philips Respironics
Icadom
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of daily physical activity measured by actimetry | 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 | Change of number of steps by day and daily energy expenditure over the 8 week period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Transition Dyspnea Index (TDI) | baseline and post use of the Vitabreath device at 4th weeks | The TDI assesses change of dyspnea perception from the BDI in each dimensions. Patient will rate score from -6 to +6 (positive score reflect improve of dyspnea and negative score reflect worse dyspnea). |
| Subjective appréciation of the device | post use of the Vitabreath device at 4th weeks | Patients will rate their appreciation of the device using 3 scale relatives to ease of use, helps recovery shortness of breath, helps to be more active in daily life |
| Change of Visual Simplified Respiratory Questionnaire (VSRQ) score | baseline and post use of the Vitabreath device at 4th weeks | The VRSQ represents health related quality of life of COPD patients |
| Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT)score | 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 | The CAT represents health related quality of life of COPD patients |
| Change of Baseline Dyspnea Index (BDI) score | baseline and post use of the Vitabreath device at 4th weeks | The BDI represents importance and impact of dyspnea in daily life of COPD patients. The BDI is one of dyspnea parameters (questionnaire). Three dimension questions include; 1.effect of daily function on dyspnea, 2. effect of magnitude of task on dyspnea and 3. effect of magnitude off effort on dyspnea. |
| Change of Modified Medical Research Council Questionnaire (mMRC) score | baseline and post use of the Vitabreath device at 4th weeks | The mMRC is one of dyspnea parameters |
Other
| Measure | Time frame | Description |
|---|---|---|
| Weight | baseline and post use of the Vitabreath device at 4th weeks | Patient will indicate their weight |
| Compliance to the device | Every week over the 4-week period | During a weekly phone call, patients will indicate the daily duration and conditions of use of the device |
| Number of acute exacerbation | Up to 12 months before the date of inclusion | Exacerbation is defined as changing the respiratory status of the patient relative to the patient's usual state, which requires acute hospitalisation. |
Countries
France
Outcome results
None listed