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

Obesity Hypoventilation Syndrome Clinical Trial

Official title:

Clinical Benefits and Tolerance to a New Ventilatory Mode in Patients With Obesity Hypoventilation Syndrome (OHS).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01757444
• Other study ID #: 2012 - A00731 - 42
• Secondary ID: EVAL CLIN - VENT
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: September 2018

Study information

• Verified date: September 2018
• Source: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoventilation
• Obesity
• Obesity Hypoventilation Syndrome
• Syndrome

Intervention

Device:
• BiPAP - A40
Patients receiving BiPAP AVAPS - AE ventilatory mode at home
• BiPAP - ST
Patients receiving BiPAP- ST mode at home.

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CHANGE IN QUALITY OF LIFE/ LEVEL OF PHYSICAL ACTIVITY/ BODY COMPOSITION		Day 1 and Day 61
Primary	CHANGE IN SLEEP QUALITY	Sleep stage, micro arousals, apnea/hypopnea index...	Day 1 and Day 61
Secondary	CHANGE IN GAZ EXCHANGE		Day 1 and Day 61