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

Study Overview
=================
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 Description
-----------------
Efficacy on sleep quality, symptoms, physical activity and quality of life

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

Conditions
-----------------
Obesity Hypoventilation Syndrome

Intervention / Treatment
-----------------
* Device: BiPAP - A40
* Device: BiPAP - ST


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man or woman, stable patient with obesity hypoventilation syndrome, naives of non invasive ventilation. PaCO2 ≥ 45 mmHg. PaO2 < 70 mmHg BMI ≥ 30Kg. m2 Exclusion Criteria: Chronic obstructive pulmonary disease Neuromuscular disease Scoliosis Cardiac insufficiency Significant psychiatric disease Sleep apnea syndrome with central apnea index > 10% Treatment with benzodiazepines at the inclusion

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BiPAP - A40<br>BiPAP with AVAPS AE mode | Device: BiPAP - A40<br>* Patients receiving BiPAP AVAPS - AE ventilatory mode at home<br>|
| Active Comparator: BiPAP- ST<br>Patients receiving BiPAP- ST at home | Device: BiPAP - ST<br>* Patients receiving BiPAP- ST mode at home.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CHANGE IN SLEEP QUALITY | Sleep stage, micro arousals, apnea/hypopnea index... | Day 1 and Day 61 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CHANGE IN GAZ EXCHANGE |  | Day 1 and Day 61 |