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Clinical outcomes related to interface type in patients with obstructive sleep apnea/hypopnea syndrome who are using continuous positive airway pressure
Massie CA, Hart RW
Chest 2003 Apr;123(4):1112-1118
clinical trial
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; 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: To evaluate the effect of interface on objective compliance, patient satisfaction, adverse effects, quality of life, and residual sleep-disordered breathing in patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) using continuous positive airway pressure (CPAP). DESIGN: Randomized, cross-over. SETTING: Two suburban community-based hospital sleep laboratories. PATIENTS: Data were collected on 39 patients with OSAHS (mean age 48.7 years), in whom CPAP was a novel treatment. INTERVENTIONS: Interventions were nasal pillows (Breeze; Mallinckrodt Corporation; Minneapolis, MN) and nasal mask (Contour; Respironics; Murrysville, PA). MEASUREMENTS AND RESULTS: Outcomes assessed at the completion of each 3-week treatment period were objective compliance, adverse effects, and satisfaction with CPAP (CPAP questionnaire), daytime sleepiness (Epworth sleepiness scale (ESS)), quality of life (Functional Outcomes of Sleep Questionnaire (FOSQ)), sleep diary, and residual sleep-disordered breathing (apnea-hypopnea index (AHI)). Patients were randomly assigned to use the nasal pillows or the nasal mask following laboratory titration and initiated on CPAP (pressure range 5 to 14 cmH2O). The percentage of days utilized favored the nasal pillows (94.1% versus 85.7%; p = 0.02), but minutes of use per night did not differ (nasal pillows, 223 min; nasal mask, 288 min). ESS scores were lower and the FOSQ total scores were higher following CPAP treatment (p < 0.001), but no differential treatment effects were noted. Fewer adverse effects, less trouble getting to sleep and staying asleep, and less air leak were reported with nasal pillows (p < 0.04). The mean +/- SD pretreatment AHI (47.1 +/- 35.1/h) was significantly lower following treatment with CPAP for both types of interface (nasal pillows, 10.2 +/- 9.8/h; nasal mask, 7.0 +/- 7.7/h; p < 0.001). CONCLUSIONS: Nasal pillows are a well-tolerated and effective interface for OSAHS patients receiving CPAP at <= 14 cmH2O. Use of nasal pillows was associated with fewer adverse effects and better sleep quality during the first 3 weeks of CPAP therapy. Further investigation is needed to determine whether interface type affects long-term CPAP use.

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