Extrait

Background and study aims Obesity is a worldwide public health issue. The main respiratory (breathing) complication caused by obesity is called obesity hypoventilation syndrome (OHS). OHS causes difficulty breathing both during the day and during sleep. OHS is an underdiagnosed and undertreated condition, despite the fact there are treatments that improve quality of life and decreases morbidity (illness) in these patients. The main treatments for patients with OHS are through providing a positive airway pressure through noninvasive ventilation (NIV). This involves the patient wearing a face mask during sleep which is connected to the machine that supplies a constant steam of pressurised air to help keep the airways open. A potential alternative treatment for patients who use NIV is a continuous positive airway pressure (CPAP) machine that is used at night. A CPAP has similarities to an NIV but provides continuous air during the night and is less expensive. The aim of this study is to test the effect of switching patients with OHS who are undergoing long term treatment with NIV, to using a CPAP and evaluate the clinical features and quality of life between these two methods of treating OHS. Who can participate? Adults with obesity hypoventilation syndrome What does the study involve? Participants undergoing treatment for OHS using NIV are switched to using a CPAP at night. This involves wearing a mask over the face or mouth that is attached to a machine that provides a continuous flow of air. Participants have night sleep recordings with a polysomnograph which is a device connected to the patient all night long to record breaks and decreases in breathing. Participants are followed up after one month of using the CPAP machine to measure their lung function and the oxygen levels in their blood. Participants also fill out a quality of life and symptoms questionnaire after one month to see if there was any change between the two different treatments. What are the possible benefits and risks of participating? There are no direct benefits or risks of participating. Where is the study run from? 1. Hôpital d'instruction des armées Alphonse Laveran (France) 2. Hôpital Nord (France) When is the study starting and how long is it expected to run for? February 2015 to March 2017 Who is funding the study? Investigator initiated and funded Who is the main contact? Dr Alain Palot

Critère d'inclusion

• Obesity hypoventilation syndrome

Liens

• isrctn