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

Not Applicable

Completed

• Conditions: Obesity Hypoventilation Syndrome
• Interventions: Device: BiPAP - ST; Device: BiPAP - A40

• Registration Number: NCT01757444
• Lead Sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

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

Study Timeline

• Study First Submitted: 2012-12-17
• Study First Submitted QC: 2012-12-21
• Study First Posted: 2012-12-31
• Study Start: 2013-06
• Status Verified: 2018-09
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Last Update Submitted: 2018-09-10
• Last Update Posted: 2018-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BiPAP- ST	BiPAP - ST	Patients receiving BiPAP- ST at home
BiPAP - A40	BiPAP - A40	BiPAP with AVAPS AE mode

Primary Outcome Measures

Name	Time	Method
CHANGE IN SLEEP QUALITY	Day 1 and Day 61	Sleep stage, micro arousals, apnea/hypopnea index...

Secondary Outcome Measures

Name	Time	Method
CHANGE IN GAZ EXCHANGE	Day 1 and Day 61

Trial Locations

Locations (11)

Centre Hospitalier Universitaire d'Angers; 🇫🇷 Angers, France

Centre Hospitalier de Béziers; 🇫🇷 Beziers, France

Hôpital Haut- Lévêque; 🇫🇷 Bordeaux, France

Centre Hospitalier de Cannes; 🇫🇷 Cannes, France

Hôpital du Bocage; 🇫🇷 Dijon, France

Clinique du Parc; 🇫🇷 Castelnau-le-Lez, France

Hôpital de Bois Guillaume; 🇫🇷 Rouen, France

Hôpital Pitié-Salpêtrière; 🇫🇷 Paris, France

Hôpital Michallon; 🇫🇷 Grenoble, France

Hôpital La Milétrie; 🇫🇷 Poitiers, France

Hôpital Larrey; 🇫🇷 Toulouse, France