Clinical trial NCT01757444: Non Invasive Ventilation : Efficacy of a New Ventilatory Mode in Patients With OHS
Official title: Clinical Benefits and Tolerance to a New Ventilatory Mode in Patients With Obesity Hypoventilation Syndrome (OHS).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity Hypoventilation Syndrome
Lead sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Sponsor class: OTHER
First posted: 2012-12-31
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: CHANGE IN SLEEP QUALITY
timeFrame: Day 1 and Day 61
Secondary outcomes:
measure: CHANGE IN GAZ EXCHANGE
timeFrame: Day 1 and Day 61
Other outcomes:
measure: CHANGE IN QUALITY OF LIFE/ LEVEL OF PHYSICAL ACTIVITY/ BODY COMPOSITION
timeFrame: Day 1 and Day 61
Locations:
city: Angers
country: France
facility: Centre Hospitalier Universitaire d'Angers
city: Beziers
country: France
facility: Centre Hospitalier de Béziers
city: Bordeaux
country: France
facility: Hôpital Haut- Lévêque
city: Cannes
country: France
facility: Centre Hospitalier de Cannes
city: Castelnau-le-Lez
country: France
facility: Clinique du Parc
city: Dijon
country: France
facility: Hôpital du Bocage
city: Grenoble
country: France
facility: Hôpital Michallon
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
city: Poitiers
country: France
facility: Hôpital La Milétrie
city: Rouen
country: France
facility: Hôpital de Bois Guillaume
city: Toulouse
country: France
facility: Hôpital Larrey
Study officials:
affiliation: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
name: Jean-François MUIR, Pr
role: PRINCIPAL_INVESTIGATOR
References: