STUDY OBJECTIVE: To determine whether fixed-pressure or variable-pressure CPAP was preferred by patients and gave better outcomes in patients with the obstructive sleep apnea/hypopnea syndrome (OSAHS). DESIGN: Randomized blinded cross-over trial with 6 weeks of fixed and 6 weeks of variable-pressure CPAP. SETTING: Sleep center. PATIENTS: 200 consecutive consenting CPAP naïve patients with daytime sleepiness and > 15 apneas + hypopneas/h after an attended auto-CPAP titration night. INTERVENTIONS:CPAP therapy using the same device (Autoset Spirit) set for 6 weeks in fixed pressure mode and for 6 weeks in variable pressure mode, the order of therapies being randomized. MEASUREMENTS AND RESULTS: All measurements were recorded at the end of each limb by a researcher blind to treatment. These included symptoms, Epworth Score, CPAP usage, objective sleepiness by modified Osler test, vigilance and health related quality of life. A total of 181 of 200 patients completed the study. At the end of the study, patients expressed no significant difference in the primary outcome, patient preference, 72 patients preferring fixed and 69 preferring variable-pressure CPAP. Epworth score was lower on variable (9.5, SEM 0.4) than fixed-pressure CPAP (10.0, SEM 0.3; P = 0.031). Mean CPAP use was higher on variable (4.2, SEM 0.2 h/night) than fixed-pressure CPAP (4.0, SEM 0.2 h/night; P = 0.047). There were no other significant differences between treatments. CONCLUSIONS This study shows no difference in patient preference and only a marginal benefit of variable over fixed-pressure CPAP in OSAHS in terms of subjective sleepiness and CPAP use. The clinical value of this difference remains to be determined. CLINICAL TRIAL INFORMATION: Variable-pressure versus fixed-pressure continuous positive airway pressure (CPAP) treatment for patients with obstructive sleep apnoea/hypopnoea syndrome (OSAHS); Registration # ISRCTN43085025.http://www.controlled-trials.com//SRCTN43085025.
RCT Entities:
STUDY OBJECTIVE: To determine whether fixed-pressure or variable-pressure CPAP was preferred by patients and gave better outcomes in patients with the obstructive sleep apnea/hypopnea syndrome (OSAHS). DESIGN: Randomized blinded cross-over trial with 6 weeks of fixed and 6 weeks of variable-pressure CPAP. SETTING: Sleep center. PATIENTS: 200 consecutive consenting CPAP naïve patients with daytime sleepiness and > 15 apneas + hypopneas/h after an attended auto-CPAP titration night. INTERVENTIONS: CPAP therapy using the same device (Autoset Spirit) set for 6 weeks in fixed pressure mode and for 6 weeks in variable pressure mode, the order of therapies being randomized. MEASUREMENTS AND RESULTS: All measurements were recorded at the end of each limb by a researcher blind to treatment. These included symptoms, Epworth Score, CPAP usage, objective sleepiness by modified Osler test, vigilance and health related quality of life. A total of 181 of 200 patients completed the study. At the end of the study, patients expressed no significant difference in the primary outcome, patient preference, 72 patients preferring fixed and 69 preferring variable-pressure CPAP. Epworth score was lower on variable (9.5, SEM 0.4) than fixed-pressure CPAP (10.0, SEM 0.3; P = 0.031). Mean CPAP use was higher on variable (4.2, SEM 0.2 h/night) than fixed-pressure CPAP (4.0, SEM 0.2 h/night; P = 0.047). There were no other significant differences between treatments. CONCLUSIONS This study shows no difference in patient preference and only a marginal benefit of variable over fixed-pressure CPAP in OSAHS in terms of subjective sleepiness and CPAP use. The clinical value of this difference remains to be determined. CLINICAL TRIAL INFORMATION: Variable-pressure versus fixed-pressure continuous positive airway pressure (CPAP) treatment for patients with obstructive sleep apnoea/hypopnoea syndrome (OSAHS); Registration # ISRCTN43085025.http://www.controlled-trials.com//SRCTN43085025.
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