Randomised trial of compliance with flexible (C-Flex) and standard continuous positive airway pressure for severe obstructive sleep apnea. [Expiratory pressure reduction (C-Flex Method) versus fix CPAP in the therapy for obstructive sleep apnoea]. A long-term randomized, cross-over comparison of auto-titrating and standard nasal continuous airway pressure. Comparison between automatic and fixed positive airway pressure therapy in the home. A randomized cross-over study of auto-continuous positive airway pressure versus fixed-continuous positive airway pressure in patients with obstructive sleep apnoea. Constant vs auto-continuous positive airway pressure in patients with sleep apnea hypopnea syndrome and a high variability in pressure requirement. Pressure-relief continuous positive airway pressure vs constant continuous positive airway pressure: a comparison of efficacy and compliance. Constant vs. automatic continuous positive airway pressure therapy: home evaluation. Preference for fixed or automatic CPAP in patients with obstructive sleep apnea syndrome.
Obstructive sleep apnea (OSA) is often treated with continuous positive airway pressure (CPAP) but the effectiveness of treatment is probably limited by poor compliance. CPAP manufacturers are thus attempting to devise more comfortable PAP devices in an effort to improve compliance. An example of such a novel device is Flexible expiratory-modulated PAP (C-Flex mode Respironics REMstar Pro, Murraysville, PA, USA).
                We aimed to compare compliance between C-Flex and standard CPAP in patients with severe OSA in a randomised controlled trial. Nineteen patients with severe OSA (mean +/- SD Apnea Hypopnea Index = 78 +/- 33/h, Epworth 14 +/- 4, PAP 8-17 cm H2O, BMI = 39 +/- 10 kg/m2) and aged 20-63 years were randomly assigned to 4 weeks of either C-Flex (setting II, n = 9) or CPAP (n = 10).
                Patients treated with C-Flex exhibited a trend toward higher compliance with their PAP devices compared to patients treated with standard CPAP (4.7 +/- 2.9 vs. 3.0 +/- 2.1 h/night, p = 0.15, effect size = 0.68). Paradoxically, improvements in subjective sleepiness (Epworth Sleepiness Scale) were greater in those who received CPAP than C-Flex (8.1 + 4.9 vs. 2.1 + 4.0 points, p = 0.014, effect size = 1.46). Improvements in objective wakefulness (Modified Maintenance of Wakefulness Test) and simple reaction times (Psychomotor Vigilance Task) were not significantly different between treatments. This randomised trial provides some evidence that C-Flex might increase initial treatment compliance, compared to CPAP, in patients with severe OSA. However, this trend toward greater compliance was not associated with better short-term treatment outcomes for patients. These findings need to be confirmed in a larger, longer-term trial. The REM star C-Flex (Fa. Respironics) was introduced in 2003. In contrast to the conventionel fix CPAP mode, the C-Flex mode is characterised by a pressure reduction at the beginning of expiration. In a randomised cross-over design, we investigated if this C-Flex-mode has advantages compared to the fix CPAP mode in terms of treatment quality and patient satisfaction.
                In this prospective randomised single-blinded cross-over study we investigated 20 patients with obstructive sleep apnoea treated with fix CPAP versus treatment with the C-Flex mode (level 2) for 6 weeks, respectively. We compared the polysomnographically measured quality of treatment and the subjective satisfaction of either form of therapy. Additionally, we measured long-term compliance of the C-Flex therapy in a 3-year follow-up with the integrated counter of the C-Flex devices.
                The mean levels of pressure of the fix CPAP and the C-Flex therapies were 8.4 +/- 2.9 mbar in both groups. There was an identical quality of treatment in terms of respiratory events, arousal index, slow wave sleep and Epworth sleepiness scale. The compliance of nocturnal use of the C-Flex and the fix CPAP was identical (6.0 +/- 0.67 C-Flex use vs. 5.8 +/- 0.98 CPAP use [h/night]). The subjective satisfaction was higher in the C-Flex mode at the end of the study since 18 of 20 patients (90%) subjectively prefered the C-Flex mode because of the easier expiration. 19 patients received a C-Flex device for long-term therapy. The 3-year-follow-up showed a regular utilisation of the C-Flex by 16 of 19 (84.2%) of these patients (mean nocturnal use 6.0 +/- 0.9 h/night). 3 of the 19 patients (15.8%) did not use their C-Flex regulary. None of the patients has terminated therapy completely.
                C-Flex mode and the conventional fix CPAP therapies show an equivalent treatment quality according to polysomnographic data. The expiratory pressure reduction compared to conventional CPAP was felt to be more comfortable by 90% of patients. The long-term-compliance as measured by regular use of the C-Flex device was 84.2% (16 out of 19 patients) after 3 years, these numbers are higher than published data on compliance with conventional CPAP therapy. This study is a 12-week randomized, cross-over, single-blind comparison of the tolerance, compliance, and symptomatic improvement obtained with standard nasal continuous positive airway pressure (CPAP) vs. an auto-titrating, self-adjusting device (APAP). Sixty newly diagnosed patients, 53 with obstructive sleep apnea (OSA) and seven with upper airway resistance syndrome were studied. Thirty-nine patients (65%) completed the 24-week protocol. Data were complete in 33. In these 33 patients CPAP and APAP reduced the Epworth Sleepiness score from 15+/-1 (+/-SEM) to 8+/-1 and 9+/-1 respectively (both <0.0001 from baseline but NS between modes). The APAP average pressure was lower than the CPAP pressure, 6.4+/-0.4 and 10.6+/-0.4 cm H20, respectively. The average daily machine use was greater with APAP, 6.0+/-0.3 hrs. versus 5.5+/-0.3 hrs. with CPAP (P < 0.04). The number of days of machine use, and the pattern of use were not different between CPAP and APAP. A higher proportion of patients who did not complete the study was randomized to CPAP for their initial treatment period. This study showed that: 1) CPAP and APAP produced an equivalent improvement in daytime sleepiness, 2) APAP pressure was lower than CPAP pressure, 3) patients wore the APAP device longer during nights they used the pressure support system, and 4) patients who began the study with APAP were more prone to continue treatment. We conclude that APAP was better tolerated and used a greater number of hours than CPAP, but the extent of improvement in excessive daytime sleepiness was similar between the two modes of therapy. We tested the hypothesis that continuous positive airway pressure (CPAP) use and outcomes can be improved by an autotitrating CPAP device in patients with obstructive sleep apnea-hypopnea syndrome (OSAHS) who require higher CPAP (10 cm H2O or more). In this multisite randomized single-blind cross-over study, 44 patients (mean age, 49 +/- 10 years) were randomized to 6 weeks at laboratory-determined fixed pressure and 6 weeks on autotitrating CPAP. Average nightly use was greater in automatic mode (306 versus 271 minutes, p = 0.005); median and 95th centile pressures in automatic mode were lower (p < 0.002). Automatic CPAP resulted in better SF-36 Vitality scores (65 +/- 20 versus 58 +/- 23, p < 0.05) and mental health scores (80 +/- 14 versus 75 +/- 18, p < 0.05), but no significant difference in Epworth score (p = 0.065). During automatic therapy, patients reported more restful sleep, better quality sleep, less discomfort from pressure, and less trouble getting to sleep for both the first week of therapy and for the averaged scores for Weeks 2-6 (all p values < 0.006). Patients who require higher fixed CPAP use autotitrating CPAP more and report greater benefit from this therapy. To compare the efficacy of auto-CPAP (AutoSet Spirit, ResMed) versus fixed-CPAP (S6 Elite, ResMed) in improving daytime sleepiness, health status, objective compliance and the ultimate treatment preference in patients with severe OSA.
                The study recruited 43 subjects aged 18-65 years with newly diagnosed severe OSA (AHI >30/h). Patients were initially treated with either auto-CPAP or fixed-CPAP for 2 months and then crossed over after a washout period of 1 week for another 2 months.
                The study was completed by 41 patients. Results are presented as mean (SE). Use of auto-CPAP in the first and the second month was significantly higher than that of fixed-CPAP [129.7 (9.9) and 130.5 (10.7) h vs 115.2 (9.5) and 113.2 (9.4) h, P = 0.04 and 0.01], whereas mean hourly use per night was 4.3 and 4.4 h versus 3.8 and 3.7 h, respectively. The Epworth sleepiness scores improved after 1 month in both treatments (13.4 to 8.5 and 8.2, P < 0.01 for both). The Sleep apnoea quality of life index improved in the first month in both compared with baseline [4.6 (0.2) to 5.0 (0.2) for auto-CPAP and 4.9 (0.2) for fixed-CPAP, P = 0.01 and 0.04, respectively], with no difference between the two treatments. Nine and 30 patients preferred auto-CPAP and fixed-CPAP, respectively, at the end of the trial, whereas 14 and 25 patients would have chosen the same treatments if cost had not been a consideration.
                Auto-CPAP and fixed-CPAP were equally effective in improving symptoms and health status in patients with severe OSA. Usage was higher with auto-CPAP, but more patients ultimately chose fixed-CPAP. Auto-continuous positive airway pressure (CPAP) has been reported to have no more efficacy than constant CPAP in unselected patients with sleep apnea hypopnea syndrome (SAHS). The aim of this study was to evaluate patients judged to be good candidates for auto-CPAP because of a high within-night variability in pressure requirement.
                Single-blind, randomized, cross-over study (2 x 8 weeks) to compare auto-CPAP with constant CPAP.
                Outpatients with moderate-to-severe SAHS attending the chest clinic.
                Patients were equipped at home in the auto-CPAP mode (model GK418A; Malinckrodt; Nancy, France), using a 4- to 14-cm H(2)O pressure range. Those individuals having a high within-night variability in pressure requirement, assessed at the end of a 14-day run-in period, were included in the cross-over study. Auto-CPAP was compared with constant CPAP (according to a titration night in the sleep laboratory) in terms of compliance, efficacy on apneas (assessed from the pressure monitor), and sleepiness (assessed on the Epworth sleepiness scale).
                Of 90 consecutive patients with SAHS, 27 patients were selected for a within-night variability in pressure requirement exceeding a given threshold. After completion of the cross-over, 24 patients were evaluable. The median percentage of nights the machine was used was 95.5% (range, 45 to 100%) on constant CPAP, and 96.5% (range, 40 to 100%) on auto-CPAP; the median apnea index recorded by the device was 0.40/h (range, 0 to 2.40/h) on constant CPAP, and 0.45/h (range, 0 to 5.80/h) on auto-CPAP (differences not significant). The mean Epworth sleepiness score was significantly (p < 0.01) lower on auto-CPAP (5.1; SD, 2.8) than on constant CPAP (6.1; SD, 2.8).
                In patients selected for a high within-night variability in pressure requirement, auto-CPAP administered via a GK418A device was equivalent to constant CPAP based on a titration night in the sleep laboratory. Subjective ratings for sleepiness were slightly lower on auto-CPAP. To compare polysomnographic data and compliance in sleep apnea patients receiving continuous positive airway pressure (CPAP) and pressure-relief CPAP (PRCPAP) [C-flex; Respironics; Murrysville, PA] as first treatment in the sleep laboratory and subsequently at home.
                A prospective, randomized, crossover design was used in the sleep laboratory, and a prospective randomized design was used at home.
                Data were collected from 52 sleep apnea patients for whom CPAP was used for the first time.
                Treatment with constant CPAP and PRCPAP.
                Patients with a first-time diagnosis of obstructive sleep apnea syndrome (OSAS) underwent conventional CPAP titration. Thereafter, polysomnography was performed at the titrated pressure using both the fixed CPAP pressure mode and the PRCPAP mode in a randomized crossover approach. The patients were then discharged home for 7 weeks of treatment with the last-applied treatment mode, and compliance data were established at the end of that time. The average apnea-hypopnea index was 53.3/h in the "diagnostic night," 5.8/h with CPAP, and 7.0/h with PRCPAP. The native arousal index was 35.2/h, 12.6/h with CPAP, and 12.9/h with PRCPAP (not significant [NS]). The central apnea index was 0.7/h with CPAP and 1.2/h with PRCPAP (p < 0.05). Compliance after 7 weeks was, on average, 9.4 min longer with PRCPAP than with CPAP (NS). Evaluation of a 13-item questionnaire showed scores of 16.4 for PRCPAP and 18.1 for constant CPAP (NS) [the fewer the complaints, the lower the score]. With regard to oral dryness, the score with PRCPAP (1.4) was significantly lower than with constant CPAP (1.9) [p < 0.05]. This difference was no longer detectable after 7 weeks.
                In terms of the effectiveness in treating obstructive sleep apnea, PRCPAP and constant CPAP are comparable. During the first night of treatment, patients receiving PRCPAP had less dryness of mouth; over a period of 7 weeks, this difference disappeared. Nightly use of the device was comparable in both groups. PRCPAP is therefore a new ventilation mode that enables effective treatment of OSAS patients. Further studies should be done to investigate the effects of expiratory pressure lowering in low-compliance patients and patients requiring CPAP > 9 cm H(2)O or experiencing dry mouth with CPAP. To compare the efficacy and patient tolerance, compliance, and preference between auto-continuous positive airway pressure (CPAP) and constant CPAP.
                Single-blinded, crossover, cohort study of consecutive patients with obstructive sleep apnea syndrome, with two treatment periods of 2 months each.
                Twenty-five patients (22 men, 3 women) with sleep apnea syndrome confirmed by ambulatory polysomnography.
                After baseline polysomnography, patients underwent in-laboratory polysomnography for titration of constant CPAP. The order of treatment was randomly allocated, either auto-CPAP and then constant CPAP, or vice versa. The auto-CPAP pressure range was 6 to 16 cm H(2)O. At the end of each 2-month period, patients underwent a control ambulatory polysomnography and received a questionnaire on subjective well-being and device evaluation. Duration of use was checked through CPAP device monitoring.
                No differences were found in apnea/hypopnea index (constant CPAP, 9.7+/-1.9 events/h vs auto-CPAP, 10.6+/-9.3 events/h), awakening/arousal index (constant CPAP, 13.7 +/- 8.0 events/h vs auto-CPAP, 15.5 +/- 8.9 events/h), slow-wave sleep duration, nocturnal saturation, or complaint of daytime sleepiness. The mean pressure required was significantly lower during auto-CPAP than during constant CPAP (8.8+/-1.8 cm H(2)O vs. 9.7+/-2.6 cm H(2)O, respectively). Patient tolerance, compliance, and duration of use were similar with both treatments.
                Auto-CPAP is as effective as constant CPAP. A wide pressure range for auto-CPAP can be used in all patients, suggesting that, in the future, use of a broad pressure range in the auto-CPAP mode could obviate the need for the titration night. The aims of this study were to compare compliance to treatment with fixed CPAP and with autoCPAP, subjective preference for type of CPAP treatment, and factors associated to preference for autoCPAP in patients with OSAS.
                Twenty-two subjects were studied in a randomized, single blind cross-over fashion. They were treated for one month by fixed CPAP (Elite Sullivan V, ResMed, Sydney, Australia) and one month by autoCPAP (Autoset T, ResMed, Sydney, Australia).
                Four subjects who stated a preference for fixed CPAP and four who expressed no preference were pooled together; fourteen preferred autoCPAP. Compliance to treatment using the two machines did not differ in the first group (3.8 (1.9) vs. 3.8 (1.5)h/day, fixed vs autoCPAP), but was higher with autoCPAP in the second group (4.8 (1.8) vs 5.5 (1.5)h/day, P<0.05). Baseline apnea/hypopnea index (AHI) was high in both groups, but was higher in the second group P<0.02. First treatment was always fixed CPAP in patients who preferred fixed CPAP, while it was either in the other subjects.
                Compliance to autoCPAP differs among OSAS patients. As long as factors predicting higher compliance to autoCPAP are not found, a trial with autoCPAP in patients poorly compliant to fixed CPAP may be warranted.
Improvement in average machine use of auto-CPAP was superior in studies with a cross-over design; the point estimate in parallel group trials was similar, but did not reach statistical significance. It is uncertain how use of machines in study settings relates to 'real world' use. Where preference was measured participants preferred auto-CPAP to fixed pressure CPAP. Further studies are required to assess the evidence for Bi-PAP, C-FlexTM and humidification. The studies assembled were characterised by high machine usage in the control groups, and low withdrawal rates. Future studies need to consider the effects of treatment in participants with more mild disease, and those who struggle to accept therapy despite persistent symptoms.