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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary: Efficacy on sleep quality, symptoms, physical activity and quality of life
Sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

Current Primary Outcome: CHANGE IN SLEEP QUALITY [ Time Frame: Day 1 and Day 61 ]

Sleep stage, micro arousals, apnea/hypopnea index...


Original Primary Outcome: Same as current

Current Secondary Outcome: CHANGE IN GAZ EXCHANGE [ Time Frame: Day 1 and Day 61 ]

Original Secondary Outcome: CHANGE IN GAZ EXCHANGE [ Time Frame: Day 1 and Day 61 ]

PaO2, PaCO2


Information By: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

Dates:
Date Received: December 17, 2012
Date Started: June 2013
Date Completion: February 2016
Last Updated: July 2, 2015
Last Verified: July 2015