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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01757444

Enrollment

Registered

2012-12-31

Start date

2013-06-30

Completion date

2018-09-30

Last updated

2018-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Hypoventilation Syndrome

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

Interventions

DEVICEBiPAP - A40

Patients receiving BiPAP AVAPS - AE ventilatory mode at home

DEVICEBiPAP - ST

Patients receiving BiPAP- ST mode at home.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
CHANGE IN SLEEP QUALITY	Day 1 and Day 61	Sleep stage, micro arousals, apnea/hypopnea index...

Secondary

Measure	Time frame
CHANGE IN GAZ EXCHANGE	Day 1 and Day 61

Other

Measure	Time frame
CHANGE IN QUALITY OF LIFE/ LEVEL OF PHYSICAL ACTIVITY/ BODY COMPOSITION	Day 1 and Day 61

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026