NCT01757444

Non Invasive Ventilation : Efficacy of a New Ventilatory Mode in Patients With OHS

Clinical Benefits and Tolerance to a New Ventilatory Mode in Patients With Obesity Hypoventilation Syndrome (OHS).

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Efficacy on sleep quality, symptoms, physical activity and quality of life

Conditions

• Obesity Hypoventilation Syndrome

Interventions

Type	Name	Description
DEVICE	BiPAP - A40	Patients receiving BiPAP AVAPS - AE ventilatory mode at home
DEVICE	BiPAP - ST	Patients receiving BiPAP- ST mode at home.

Timeline

• Start date: 2013-06-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2012-12-31
• Last updated: 2018-09-11

Locations

11 sites across 1 country: France