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Comfort and pressure profiles of two auto-adjustable positive airway pressure devices: a technical report
Hertegonne KB, Proot PM, Pauwels RA, Pevernagie DA
Respiratory Medicine 2003 Aug;97(8):903-908
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: Yes; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

STUDY OBJECTIVES: The purpose of this study was to compare comfort parameters and pressure profiles of the AutoSet (Resmed) and the SOMNOsmart (Weinmann), two auto-adjustable positive airway pressure (APAP) devices. SETTING: The sleep disorders center of a university hospital. DESIGN: A single-blind randomized trial protocol was applied. A split night procedure allowed each patient to be treated in a crossover fashion with both APAP devices during one overnight study. PATIENTS AND METHODS: Fifty consecutive obstructive sleep apnea (OSA) patients were recruited. Each patient filled out an evaluation form for both devices after the study night. Visual analogue scales were used to score four comfort measures. Three CPAP outcomes generated by the devices (P50, P95 and Pmax) were assessed, compared with each other and correlated with the individually predicted CPAP (Ppred). RESULTS: Forty-five males and 5 females, mean age 53.0 years, body mass index 31.0, were included. The mean apnea-hypopnea index was 58.7, the mean arousal index was 54.3. Mean CPAP-compliance before the titration study was 4.9 h per night. Comparison of the two devices regarding the effect on the subjective sleep quality parameters showed no differences. The AutoSet pressure outcomes correlated significantly better with Ppred in comparison with the SOMNOsmart. The P50 and P95 but not the Pmax values were significantly lower in the SOMNOsmart as compared with the AutoSet (P50: 5.1 +/- 1.3 versus 7.1 +/- 1.9 mbar, p < 0.0001; P95: 7.8 +/- 3.0 versus 9.6 +/- 1.9 mbar, p < 0.0005; Pmax: 10.0 +/- 3.4 versus 10.8 +/- 1.8 mbar, NS). CONCLUSION: While the subjective tolerance of the two APAP machines was comparable, these devices were characterized by different pressure profiles. The pressure parameters of the AutoSet correlated better with Ppred than those of the SOMNOsmart.

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