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| Name | Class |
|---|---|
| Philips Respironics | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Noninvasive ventilation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Invasive Ventilation | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of daily physical activity measured by actimetry | Change of number of steps by day and daily energy expenditure over the 8 week period | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Baseline Dyspnea Index (BDI) score | 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. | baseline and post use of the Vitabreath device at 4th weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance to the device | During a weekly phone call, patients will indicate the daily duration and conditions of use of the device | Every week over the 4-week period |
| Number of acute exacerbation | Exacerbation is defined as changing the respiratory status of the patient relative to the patient's usual state, which requires acute hospitalisation. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Louis PEPIN, Pr | Laboratoire du sommeil - Centre hospitalier Universitaire Michallon - 38043 GRENOBLE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Michèle Bognie Pneumology Office | Alès | 30100 | France | |||
| Clinique du Parc |
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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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| Change of Modified Medical Research Council Questionnaire (mMRC) score | The mMRC is one of dyspnea parameters | baseline and post use of the Vitabreath device at 4th weeks |
| Change of Transition Dyspnea Index (TDI) | 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). | baseline and post use of the Vitabreath device at 4th weeks |
| Subjective appréciation of the device | 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 | post use of the Vitabreath device at 4th weeks |
| Change of Visual Simplified Respiratory Questionnaire (VSRQ) score | The VRSQ represents health related quality of life of COPD patients | baseline and post use of the Vitabreath device at 4th weeks |
| Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT)score | The CAT represents health related quality of life of COPD patients | 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 |
| Up to 12 months before the date of inclusion |
| Weight | Patient will indicate their weight | baseline and post use of the Vitabreath device at 4th weeks |
| Castelnau-le-Lez |
| 34000 |
| France |
| CHU Grenoble-Alpes | Grenoble | 38043 | France |
| Hôpital Privé La Louvière | Lille | 59042 | France |
| Dr Christian PAILLARGUELO Pneumology Office | Lunel | 34400 | France |
| CHU Caremeau | Nîmes | 30900 | France |
| Clinique Pasteur | Toulouse | 31300 | France |