Extrait

Background and study aims Obstructive sleep apnea in its severe form is treated by Continuous Positive Airway Pressure (CPAP). CPAP delivers positive pressure in the upper airway of the patient through a nasal mask or nasal-oral mask and a circuit during sleep. The benefits of CPAP treatment have been extensively researched. It has been established that the more a patient uses treatment during sleep the better the clinical benefit is. However, the number of patients not using the device properly or who stop using the device after one year is high. The major challenges of CPAP treatment are to reduce constraints surrounding the use of the device and to maximize the amount of time used during sleep. The aim of the study is to assess the comfort and subjective satisfaction of patients using a CPAP new generation (PR1-PFlex) with advanced technology for comfort. Who can participate? Patients with Obstructive Sleep Apnoea Syndrome (OSAS) using an existing device. What does the study involve? The patients will undergo a medical examination. They will complete a series of questionnaires and data will be obtained from their current device. After seven days, they will be visited at home and the study device will be given to the patient and explained. After the study device has been used for about seven days the patient will be sent in the post some questionnaires to complete and a new data recording card. The patient will need to return the completed questionnaires and the data recording card from the study device to the investigator. Full instructions will be given to the patient. What are the possible benefits and risks of participating? The PR1-Pflex device has a current CE mark, is available for sale in Europe and will be used within the scope of its intended use in this study. The benefit to patients with OSAS is to use a more comfortable CPAP device which should significantly reduce the pressure level without impacting the effectiveness of treatment. Apart from known minor risks relating to CPAP, there are no additional risks or benefits. Where is the study run from? Centre du Sommeil Département inter-hospitalier de Physiologie Explorations Fonctionnelles Bichat – Louis Mourier Hôpital Bichat – Claude Bernard 46 Rue Henri Huchard 75018 Paris, FRANCE Hôpital Béclère Service d’Explorations Fonctionnelles Multidisciplinaires 157 rue de la Porte de Trivaux 92141 Clamart, FRANCE Hôpital Ambroise Paré Service de Physiologie/Explorations Fonctionnelles 9 avenue Charles de Gaulle 92104 Boulogne-Billancourt, FRANCE Hôpital La Pitié Salpétrière Laboratoire du Sommeil/pavillon Marguerite Bottard 47-83 Bd de l'Hôpital 75651 Paris Cédex 13, FRANCE Hôpital Tenon Service Explorations Fonctionnelles Multidisciplinaires 4 rue de la Chine 75020 Paris, FRANCE Centre Hospitalier de Gonesse Centre des E.F.N 25 rue Bernard Février 95500 Gonesse, FRANCE Centre Hospitalier de Compiègne Service de Pneumologie et Unité des pathologies du sommeil 8 Avenue Henri Adnot, ZAC de Mercières 3 60200 Compiègne, FRANCE Polyclinique Saint Laurent 2 ter rue du Saint Laurent 35706 Rennes, FRANCE Cabinet de Pneumologie 17 rue Rivière 33000 Bordeaux, FRANCE Polyclinique Aguilera 21 rue Estagnas 64204 Biarritz, FRANCE Nouvelle Clinique de L'Union Boulevard de Ratalens BP 24336 – SAINT-JEAN 31240 L'Union, FRANCE Polyclinique des Fleurs 332 avenue Frédéric Mistral 83190 Ollioules, FRANCE Centre Hospitalier Nord de Marseille Service de Pneumologie Chemin des Bourrely 13915 Marseille, FRANCE Centre Hospitalier Privé de Saint Brieuc Polyclinique du Littoral 58 rue La Fayette 22000 Saint Brieuc, FRANCE When is the study starting and how long is it expected to run? It is anticipated that recruitment will start in May 2013. 110 participants will be enrolled for 5 months. Who is funding the study? Philips Home Healthcare Solutions (France). Who is the main contact? Ms Linda Makhlouf [email protected]

Critère d'inclusion

• Obstructive Sleep Apnea

Liens

• ictrp
• isrctn