Non Invasive Ventilation : Efficacy of a New Ventilatory Mode in Patients With OHS
Primary Purpose
Obesity Hypoventilation Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
BiPAP - A40
BiPAP - ST
Sponsored by
About this trial
This is an interventional treatment trial for Obesity Hypoventilation Syndrome
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
Sites / Locations
- Centre Hospitalier Universitaire d'Angers
- Centre Hospitalier de Béziers
- Hôpital Haut- Lévêque
- Centre Hospitalier de Cannes
- Clinique du Parc
- Hôpital du Bocage
- Hôpital Michallon
- Hôpital Pitié-Salpêtrière
- Hôpital La Milétrie
- Hôpital de Bois Guillaume
- Hôpital Larrey
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BiPAP - A40
BiPAP- ST
Arm Description
BiPAP with AVAPS AE mode
Patients receiving BiPAP- ST at home
Outcomes
Primary Outcome Measures
CHANGE IN SLEEP QUALITY
Sleep stage, micro arousals, apnea/hypopnea index...
Secondary Outcome Measures
CHANGE IN GAZ EXCHANGE
Full Information
NCT ID
NCT01757444
First Posted
December 17, 2012
Last Updated
September 10, 2018
Sponsor
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
1. Study Identification
Unique Protocol Identification Number
NCT01757444
Brief Title
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
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity Hypoventilation Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BiPAP - A40
Arm Type
Experimental
Arm Description
BiPAP with AVAPS AE mode
Arm Title
BiPAP- ST
Arm Type
Active Comparator
Arm Description
Patients receiving BiPAP- ST at home
Intervention Type
Device
Intervention Name(s)
BiPAP - A40
Intervention Description
Patients receiving BiPAP AVAPS - AE ventilatory mode at home
Intervention Type
Device
Intervention Name(s)
BiPAP - ST
Intervention Description
Patients receiving BiPAP- ST mode at home.
Primary Outcome Measure Information:
Title
CHANGE IN SLEEP QUALITY
Description
Sleep stage, micro arousals, apnea/hypopnea index...
Time Frame
Day 1 and Day 61
Secondary Outcome Measure Information:
Title
CHANGE IN GAZ EXCHANGE
Time Frame
Day 1 and Day 61
Other Pre-specified Outcome Measures:
Title
CHANGE IN QUALITY OF LIFE/ LEVEL OF PHYSICAL ACTIVITY/ BODY COMPOSITION
Time Frame
Day 1 and Day 61
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-François MUIR, Pr
Organizational Affiliation
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire d'Angers
City
Angers
Country
France
Facility Name
Centre Hospitalier de Béziers
City
Beziers
Country
France
Facility Name
Hôpital Haut- Lévêque
City
Bordeaux
Country
France
Facility Name
Centre Hospitalier de Cannes
City
Cannes
Country
France
Facility Name
Clinique du Parc
City
Castelnau-le-Lez
Country
France
Facility Name
Hôpital du Bocage
City
Dijon
Country
France
Facility Name
Hôpital Michallon
City
Grenoble
Country
France
Facility Name
Hôpital Pitié-Salpêtrière
City
Paris
Country
France
Facility Name
Hôpital La Milétrie
City
Poitiers
Country
France
Facility Name
Hôpital de Bois Guillaume
City
Rouen
Country
France
Facility Name
Hôpital Larrey
City
Toulouse
Country
France
12. IPD Sharing Statement
Learn more about this trial
Non Invasive Ventilation : Efficacy of a New Ventilatory Mode in Patients With OHS
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