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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01757444
Recruitment Status : Completed
First Posted : December 31, 2012
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
DELRIEU Jacqueline, 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.

Condition or disease Intervention/treatment Phase
Obesity Hypoventilation Syndrome Device: BiPAP - A40 Device: BiPAP - ST Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Benefits and Tolerance to a New Ventilatory Mode in Patients With Obesity Hypoventilation Syndrome (OHS).
Study Start Date : June 2013
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018

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.




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


Secondary Outcome Measures :
  1. CHANGE IN GAZ EXCHANGE [ Time Frame: Day 1 and Day 61 ]

Other Outcome Measures:
  1. CHANGE IN QUALITY OF LIFE/ LEVEL OF PHYSICAL ACTIVITY/ BODY COMPOSITION [ Time Frame: Day 1 and Day 61 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757444


Locations
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France
Centre Hospitalier Universitaire d'Angers
Angers, France
Centre Hospitalier de Béziers
Beziers, France
Hôpital Haut- Lévêque
Bordeaux, France
Centre Hospitalier de Cannes
Cannes, France
Clinique du Parc
Castelnau-le-Lez, France
Hôpital du Bocage
Dijon, France
Hôpital Michallon
Grenoble, France
Hôpital Pitié-Salpêtrière
Paris, France
Hôpital La Milétrie
Poitiers, France
Hôpital de Bois Guillaume
Rouen, France
Hôpital Larrey
Toulouse, France
Sponsors and Collaborators
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Investigators
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Principal Investigator: Jean-François MUIR, Pr Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
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Responsible Party: DELRIEU Jacqueline, Coordinator, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
ClinicalTrials.gov Identifier: NCT01757444    
Other Study ID Numbers: 2012 - A00731 - 42
EVAL CLIN - VENTILATEUR ( Other Identifier: ANTADIR )
First Posted: December 31, 2012    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Hypoventilation
Obesity Hypoventilation Syndrome
Obesity
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