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The study is based on the assumption that in the Overlap Syndrome, the introduction at home of the NIV is as effective in terms of compliance and clinical and gazometric improvement, and life quality, that setting hospital start up. The investigators will study the initiation of NIV at home versus in hospital in two randomized Overlap Syndrome patient groups. The main objective of the study is to demonstrate the non-inferiority of the initiation of the NIV at home versus hospital in terms of compliance.
The Overlap Syndrome is defined by the coexistence of chronic obstructive pulmonary disease (COPD) and an apnea - hypopnea syndrome obstructive sleep (SAHS). The interaction between these two diseases is responsible for deepest nocturnal desaturation, decreased sensitivity to CO2, more pronounced sleep alterations, more frequent daytime hypercapnia, a higher risk of hypertension pulmonary and increased cardiovascular risk, compared to subjects with COPD or isolated SAHS.
The Overlap Syndrome treatments are continuous positive airway pressure (CPAP) or non-invasive ventilation (NIV), associated complemented or not by oxygen therapy during sleep. The criteria for choosing the type of treatment are not well defined. Quality and compliance of the NIV are very important in all diseases leading to chronic respiratory failure whose Overlap Syndrome. The increase in the number of patients treated with NIV is estimated at over 12% per year. The NIV startup is usually performed in a conventional hospitalization but congestion healthcare pathways lead to increase waiting time before treatment. Thus, to date, no study has validated a supported alternative to meet the increase in the number of patients on NIV while maintaining quality service.
The HAS has defined good candidates for a NIV home based startup, on the following criteria: patients with a recognized indication of NIV in the long term , with stable respiratory failure, requiring only nocturnal ventilation, surrounded by caregivers mastering the use of equipment and whose location allows rapid intervention. The study is based on the assumption that in the Overlap Syndrome, the introduction at home of the NIV is as effective in terms of compliance and clinical and gazometric improvement, and life quality, that setting hospital start up. The investigators will study the initiation of NIV at home versus in hospital in two randomized Overlap Syndrome patient groups. The main objective of the study is to demonstrate the non-inferiority of the initiation of the NIV at home versus hospital in terms of compliance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IniVAH | Active Comparator | Initiation of the NIV in hospital : current care. 3 days hospitalization to start-up the NIV as usual. |
|
| IniVAD | Experimental | Initiation of the NIV at home : experimental care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IniVAH | Other | Initiation of the NIV during a 3 days hospitalization as usual. |
|
| Measure | Description | Time Frame |
|---|---|---|
| compliance- average adherence measured over the three months under NIV expressed in hours/night | month 3 (M3) |
| Measure | Description | Time Frame |
|---|---|---|
| quality of ventilation : evolution of the pCO2 and nocturnal saturation at M3 | month 3 (M3) | |
| quality of life and satisfaction of the patients : patient life satisfaction questionnaire | month 3 (M3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Géraldine Boy, PhD | Contact | 0607434961 | geraldine.boy@ipsante.com | |
| Safia Maaradji-Gati, MD | Contact | 0674038420 | safia.maaradji-Gati@ipsante.com |
| Name | Affiliation | Role |
|---|---|---|
| Safia Maaradji-Gati, MD | IPSanté Domicile | Study Director |
| Jésus Gonzalez, MD | La Pitié-Salpétrière | Principal Investigator |
| Marie Pia D'orthor, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Annecy-Genevois | Not yet recruiting | Annecy | 74374 | France |
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| IniVAD | Other | Initiation of the NIV at home. The first day, the kinesiologist and the technician start-up the NIV at home with the patient. The investigator will validate the adjustment settings proposed by the kinesiologist. No procedure during the second day as described by the HAS. The third day, the kinesiologist and the technician come back to the patient home so as to adjust the settings if needed and if validated by the investigator. |
|
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| the occurrence of complications : number of NIV complication occurred | month 3 |
| economic study- number of hospitalization nights | month 3 (M3) |
| economic study- number of intervention of the kinesiologist and the technician | month 3 (M3) |
| economic study- number of phone contact by the patient | month 3 (M3) |
| Hôpital Bichat - Claude Bernard |
| Principal Investigator |
| Clinique Chirurgicale Bel-Air | Recruiting | Bordeaux | 33073 | France |
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| CH Cannes | Not yet recruiting | Cannes | 06401 | France |
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| CHU Dijon | Not yet recruiting | Dijon | 21000 | France |
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| CH Intercommunal du Val d'Ariège | Not yet recruiting | Foix | 09017 | France |
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| Hôpital Raymond Poincaré | Not yet recruiting | Garches | 92380 | France |
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| CHU de Grenoble site Nord - Hôpital Albert Michallon | Not yet recruiting | Grenoble | 38043 | France |
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| Centre Hospitalier Haguenau | Not yet recruiting | Haguenau | 67500 | France |
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| Clinique Du Blanc Mesnil | Recruiting | Le Blanc-Mesnil | 93150 | France |
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| Clinique Mutualiste du Medoc | Not yet recruiting | Lesparre-Médoc | 33340 | France |
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| CHR - Hôpital Calmette | Not yet recruiting | Lille | 59037 | France |
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| CHU Bichat - Claude Bernard | Recruiting | Paris | 75018 | France |
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| CHU La Pitié-salpétrière | Not yet recruiting | Paris | 75651 | France |
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| Clinique Saint Laurent | Recruiting | Rennes | 35700 | France |
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| Institut Arnault Tzanck | Not yet recruiting | Saint-Laurent-du-Var | 06721 | France |
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| CHU de Strasbourg - Hôpital Civil | Not yet recruiting | Strasbourg | 67091 | France |
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| Hôpital Larrey CHU Toulouse | Not yet recruiting | Toulouse | 31053 | France |
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