Pressure reduction during exhalation in sleep apnea patients treated by continuous positive airway pressure
Chest. 2009-08-01; 136(2): 490-497
DOI: 10.1378/chest.08-2646
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1. Chest. 2009 Aug;136(2):490-497. doi: 10.1378/chest.08-2646. Epub 2009 Jun 30.
Pressure reduction during exhalation in sleep apnea patients treated by
continuous positive airway pressure.
Pépin JL(1), Muir JF(2), Gentina T(3), Dauvilliers Y(4), Tamisier R(5), Sapene
M(6), Escourrou P(7), Fleury B(8), Philip-Joet F(9), Philip P(10), d’Ortho
MP(11).
Author information:
(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: .
(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.
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 apnea 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.
DOI: 10.1378/chest.08-2646
PMID: 19567496 [Indexed for MEDLINE]