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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
First received
Last updated
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
Health authority
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

Study Design


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
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