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| ID | Type | Description | Link |
|---|---|---|---|
| EVAL CLIN - VENTILATEUR | Other Identifier | ANTADIR |
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In 2012, it has announced the availability of the new ventilator (BiPAP- A40), which could offer potential advantages over fixed level pressure support, in particular, in patients with obesity hypoventilation syndrome (OHS). One of the key benefits of the BiPAP A40 is an innovative ventilation mode called AVAPS-AE, which automatically maintains airway patency while delivering the correct level of ventilation each user requires, whatever their body position or sleep stage. AVAPS-AE mode is also aimed to help the clinicians during the initial titration of therapy, while providing long term comfort and assuring therapy compliance. However, studies on the physiologic and clinical effects have not yet been performed. The aim of our singled-blind randomised multicentre controlled trial is to prospectively investigate the effects of BiPAP with the spontaneous/timed (S/T) or the AVAPS-AE ventilation mode over 8 weeks on sleep quality, ventilation pattern, gas exchange, symptoms, body composition, level of physical activity and health-related quality of life in OHS patients.
Efficacy on sleep quality, symptoms, physical activity and quality of life
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BiPAP - A40 | Experimental | BiPAP with AVAPS AE mode |
|
| BiPAP- ST | Active Comparator | Patients receiving BiPAP- ST at home |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BiPAP - A40 | Device | Patients receiving BiPAP AVAPS - AE ventilatory mode at home |
| |
| Measure | Description | Time Frame |
|---|---|---|
| CHANGE IN SLEEP QUALITY | Sleep stage, micro arousals, apnea/hypopnea index... | Day 1 and Day 61 |
| Measure | Description | Time Frame |
|---|---|---|
| CHANGE IN GAZ EXCHANGE | Day 1 and Day 61 |
| Measure | Description | Time Frame |
|---|---|---|
| CHANGE IN QUALITY OF LIFE/ LEVEL OF PHYSICAL ACTIVITY/ BODY COMPOSITION | Day 1 and Day 61 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-François MUIR, Pr | Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire d'Angers | Angers | France | ||||
| Centre Hospitalier de Béziers |
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| BiPAP - ST |
| Device |
Patients receiving BiPAP- ST mode at home. |
|
| Béziers |
| France |
| Hôpital Haut- Lévêque | Bordeaux | France |
| Centre Hospitalier de Cannes | Cannes | France |
| Clinique du Parc | Castelnau-le-Lez | France |
| Hôpital du Bocage | Dijon | France |
| Hôpital Michallon | Grenoble | France |
| Hôpital Pitié-Salpêtrière | Paris | France |
| Hôpital La Milétrie | Poitiers | France |
| Hôpital de Bois Guillaume | Rouen | France |
| Hôpital Larrey | Toulouse | France |
| ID | Term |
|---|---|
| D010845 | Obesity Hypoventilation Syndrome |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D007040 | Hypoventilation |
| D012131 | Respiratory Insufficiency |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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