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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Patients receiving BiPAP AVAPS - AE ventilatory mode at home
Patients receiving BiPAP- ST mode at home.
Centre Hospitalier Universitaire d'Angers
Angers, France
Centre Hospitalier de Béziers
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
...and 1 more locations
CHANGE IN SLEEP QUALITY
Sleep stage, micro arousals, apnea/hypopnea index...
Time frame: Day 1 and Day 61
CHANGE IN GAZ EXCHANGE
Time frame: Day 1 and Day 61
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.