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).

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.

Study Overview

• Status: Completed
• Conditions: Obesity Hypoventilation Syndrome
• Intervention / Treatment: Device: BiPAP - A40; Device: BiPAP - ST

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France
    • Centre Hospitalier Universitaire d'Angers
  • Beziers, France
    • Centre Hospitalier de Beziers
  • Bordeaux, France
    • Hôpital haut- lévêque
  • Cannes, France
    • Centre Hospitalier de Cannes
  • Castelnau-le-Lez, France
    • Clinique du Parc
  • Dijon, France
    • Hôpital du Bocage
  • Grenoble, France
    • Hôpital Michallon
  • Paris, France
    • Hôpital Pitié-Salpêtrière
  • Poitiers, France
    • Hôpital la Milétrie
  • Rouen, France
    • Hôpital de Bois Guillaume
  • Toulouse, France
    • Hôpital Larrey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

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	Time Frame
CHANGE IN GAZ EXCHANGE	Day 1 and Day 61

Other Outcome Measures

Outcome Measure	Time Frame
CHANGE IN QUALITY OF LIFE/ LEVEL OF PHYSICAL ACTIVITY/ BODY COMPOSITION	Day 1 and Day 61

Collaborators and Investigators

• Sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
• Investigators: Principal Investigator: Jean-François MUIR, Pr, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: December 17, 2012
• First Submitted That Met QC Criteria: December 21, 2012
• First Posted (Estimate): December 31, 2012

Study Record Updates

• Last Update Posted (Actual): September 11, 2018
• Last Update Submitted That Met QC Criteria: September 10, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Respiratory Insufficiency; Sleep Apnea, Obstructive; Syndrome; Obesity; Hypoventilation; Obesity Hypoventilation Syndrome
• Other Study ID Numbers: 2012 - A00731 - 42; EVAL CLIN - VENTILATEUR (Other Identifier: ANTADIR)