CLINICAL TRIAL
COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
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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.

Chest 2003 April
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 cm H(2)O). The percentage of days utilized favored the nasal pillows (94.1% vs 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 < or = 14 cm H(2)O. 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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