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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Sponsor:
Information provided by (Responsible Party):
DELRIEU Jacqueline, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
ClinicalTrials.gov Identifier:
NCT01757444
First received: December 17, 2012
Last updated: July 2, 2015
Last verified: July 2015
  Purpose
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.

Condition Intervention
Obesity Hypoventilation Syndrome
Device: BiPAP - A40
Device: BiPAP - ST

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Clinical Benefits and Tolerance to a New Ventilatory Mode in Patients With Obesity Hypoventilation Syndrome (OHS).

Further study details as provided by Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche:

Primary Outcome Measures:
  • CHANGE IN SLEEP QUALITY [ Time Frame: Day 1 and Day 61 ] [ Designated as safety issue: Yes ]
    Sleep stage, micro arousals, apnea/hypopnea index...


Secondary Outcome Measures:
  • CHANGE IN GAZ EXCHANGE [ Time Frame: Day 1 and Day 61 ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • CHANGE IN QUALITY OF LIFE/ LEVEL OF PHYSICAL ACTIVITY/ BODY COMPOSITION [ Time Frame: Day 1 and Day 61 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: June 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:
Efficacy on sleep quality, symptoms, physical activity and quality of life
  Eligibility

Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01757444

Contacts
Contact: Jacqueline DELRIEU, Ph.D delrieu@antadir.com

Locations
France
Centre Hospitalier Universitaire d'Angers Recruiting
Angers, France
Contact: Frédéric GAGNADOUX, Pr         
Centre Hospitalier de Béziers Recruiting
Beziers, France
Contact: Frederic GOUTORBE, MD         
Hôpital Haut- Lévêque Active, not recruiting
Bordeaux, France
Centre Hospitalier de Cannes Recruiting
Cannes, France
Contact: Christophe PERRIN, MD         
Clinique du Parc Recruiting
Castelnau-le-Lez, France
Contact: Christophe BROUSSE, MD         
Hôpital du Bocage Recruiting
Dijon, France
Contact: Claudio RABEC, MD         
Hôpital Michallon Recruiting
Grenoble, France
Contact: Jean Louis PEPIN, Pr         
Hôpital Pitié-Salpêtrière Recruiting
Paris, France
Contact: Thomas SIMILOWSKI, Pr         
Hôpital La Milétrie Recruiting
Poitiers, France
Contact: Jean Claude MEURICE, Pr         
Hôpital de Bois Guillaume Recruiting
Rouen, France
Contact: Jean François MUIR, Pr       Jean-Francois.Muir@chu-rouen.fr   
Hôpital Larrey Active, not recruiting
Toulouse, France
Sponsors and Collaborators
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
  More Information

Responsible Party: DELRIEU Jacqueline, Coordinator, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
ClinicalTrials.gov Identifier: NCT01757444     History of Changes
Other Study ID Numbers: 2012 - A00731 - 42  EVAL CLIN - VENTILATEUR 
Study First Received: December 17, 2012
Last Updated: July 2, 2015
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Syndrome
Obesity
Hypoventilation
Obesity Hypoventilation Syndrome
Disease
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 26, 2016