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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
Sponsor:
Information provided by (Responsible Party):
COUILLARD Annabelle, Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
ClinicalTrials.gov Identifier:
NCT01757444
First received: December 17, 2012
Last updated: March 4, 2014
Last verified: March 2014
  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).

Resource links provided by NLM:


Further study details as provided by Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire:

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 2015
Estimated Primary Completion Date: December 2014 (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 80 Years
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: Annabelle COUILLARD, Ph.D annabelle.couillard@yahoo.fr

Locations
France
Centre Hospitalier de Béziers Active, not recruiting
Beziers, France
Hôpital Haut- Lévêque Active, not recruiting
Bordeaux, France
Centre Hospitalier de Cannes Active, not recruiting
Cannes, France
Hôpital du Bocage Active, not recruiting
Dijon, France
Hôpital Michallon Active, not recruiting
Grenoble, France
Hôpital Pitié-Salpêtrière Active, not recruiting
Paris, France
Hôpital La Milétrie Active, not recruiting
Poitiers, France
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 le Traitement à Domicile de l'Insuffisance Respiratoire
Investigators
Principal Investigator: Jean-François MUIR, Pr Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
  More Information

No publications provided

Responsible Party: COUILLARD Annabelle, Coordinator, Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
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: March 4, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

ClinicalTrials.gov processed this record on October 22, 2014