Jean-Louis Pépin1, Jean-François Muir2, Thibaut Gentina3, Yves Dauvilliers4, Renaud Tamisier5, Marc Sapene6, Pierre Escourrou7, Bernard Fleury8, François Philip-Joet9, Pierre Philip10, Marie-Pia d'Ortho11. 1. HP2 Laboratory, Institut National de la Santé et de la Recherche Médicale (INSERM), Equipe Région INSERM 17, Grenoble University Hospital, Grenoble, France. Electronic address: JPepin@chu-grenoble.fr. 2. Service de Pneumologie, Hôpital Boisguillaume, Rouen, France. 3. Clinique de La Louvière, Lille, France. 4. University Hospital of Montpellier, Montpellier, France. 5. HP2 Laboratory, Institut National de la Santé et de la Recherche Médicale (INSERM), Equipe Région INSERM 17, Grenoble University Hospital, Grenoble, France. 6. Polyclinique de Bordeaux, Bordeaux, France. 7. Service de Physiologie-Explorations Fonctionnelles, Hôpital A. Béclère, Assistance Publique-Hôpitaux de Paris, Clamart, France. 8. Service de Pneumologie, Hôpital St Antoine, Assistance Publique-Hôpitaux de Paris, Paris, France. 9. Service de Pneumologie, Hôpital St Joseph, Assistance Publique-Hôpitaux de Marseille, Marseille, France. 10. Service de Physiologie-Explorations Fonctionnelles, Hôpital Pellegrin, Bordeaux, France. 11. Groupe Henri-Mondor Albert Chennevier, Service de Physiologie-Explorations Fonctionnelles, Assistance Publique-Hôpitaux de Paris, Créteil, France; Institut National de la Santé et de la Recherche Médicale (INSERM), Unité 841, Créteil, F-94010 France; Université Paris-7-Denis Diderot, Faculté de Médecine Xavier Bichat, Paris, France.
Abstract
INTRODUCTION: This French, multicenter, randomized double-blind controlled trial tested the hypothesis that pressure reduction during exhalation (C-Flex; Respironics; Murrysville, PA) would improve continuous positive airway pressure (CPAP) compliance, comfort, and quality of life. METHODS:Two hundred eighteen newly diagnosed sleepapnea patients (seven centers; mean [+/- SD] age, 55 +/- 11 years; mean body mass index, 31 +/- 6 kg/m(2); mean apnea-hypopnea index, 44 +/- 21 events/h) were randomly assigned to receive 3 months of treatment with CPAP (108 patients) or C-Flex (110 patients). Objective compliance, generic quality-of-life questionnaire (SF-36) scores, disease-specific quality-of-life questionnaire (Grenoble Sleep Apnea Quality of Life [GrenobleSAQOL]) scores, and visual analog scales for CPAP comfort and side effects were determined at baseline and after 3 months. After 3 months, patients in the CPAP arm were moved to the C-Flex arm for 3 additional months (open study). RESULTS: An intention-to-treat analysis demonstrated that there were no differences at 3 months between C-Flex and CPAP use in terms of compliance, the rate of side effects, and comfort. Low compliers receiving CPAP therapy (< 4 h of use) significantly improved this outcome during the open study (p = 0.04). There was a significant improvement in six of eight of the SF-36 domain scores and in all of the domains of the GrenobleSAQOL scores in both groups using either CPAP or C-Flex. CONCLUSION: In unselected sleep apnea patients, C-Flex was associated with similar outcomes to standard CPAP. Low compliers receiving CPAP therapy improved their adherence when moving to C-Flex. TRIAL REGISTRATION: ISRCTN Register Identifier: 08065291.
RCT Entities:
INTRODUCTION: This French, multicenter, randomized double-blind controlled trial tested the hypothesis that pressure reduction during exhalation (C-Flex; Respironics; Murrysville, PA) would improve continuous positive airway pressure (CPAP) compliance, comfort, and quality of life. METHODS: Two hundred eighteen newly diagnosed sleep apneapatients (seven centers; mean [+/- SD] age, 55 +/- 11 years; mean body mass index, 31 +/- 6 kg/m(2); mean apnea-hypopnea index, 44 +/- 21 events/h) were randomly assigned to receive 3 months of treatment with CPAP (108 patients) or C-Flex (110 patients). Objective compliance, generic quality-of-life questionnaire (SF-36) scores, disease-specific quality-of-life questionnaire (Grenoble Sleep Apnea Quality of Life [GrenobleSAQOL]) scores, and visual analog scales for CPAP comfort and side effects were determined at baseline and after 3 months. After 3 months, patients in the CPAP arm were moved to the C-Flex arm for 3 additional months (open study). RESULTS: An intention-to-treat analysis demonstrated that there were no differences at 3 months between C-Flex and CPAP use in terms of compliance, the rate of side effects, and comfort. Low compliers receiving CPAP therapy (< 4 h of use) significantly improved this outcome during the open study (p = 0.04). There was a significant improvement in six of eight of the SF-36 domain scores and in all of the domains of the GrenobleSAQOL scores in both groups using either CPAP or C-Flex. CONCLUSION: In unselected sleep apneapatients, C-Flex was associated with similar outcomes to standard CPAP. Low compliers receiving CPAP therapy improved their adherence when moving to C-Flex. TRIAL REGISTRATION: ISRCTN Register Identifier: 08065291.
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