A prospective 8 week trial of nasal interfaces vs. a novel oral interface (Oracle) for treatment of obstructive sleep apnea hypopnea syndrome. Clinical outcomes related to interface type in patients with obstructive sleep apnea/hypopnea syndrome who are using continuous positive airway pressure. Comparison of nose and face mask CPAP therapy for sleep apnoea. Nasal-CPAP, surgery, and conservative management for treatment of obstructive sleep apnea syndrome. A randomized study.
To compare efficacy, compliance rates, and side effects of a new strapless oral interface, the Oracle, with available nasal masks over 8 weeks of use for the treatment of obstructive sleep apnea hypopnea syndrome (OSAHS).
                A total of 38 patients with OSAHS (respiratory disturbance index (RDI) >/=15/h) were enrolled after the diagnostic polysomnogram for subsequent continuous positive airway pressure (CPAP) therapy. After randomization, therapeutic pressures during a titration study were determined for 21 patients in the oral group and 17 patients in the nasal group. Comparisons for nasal and oral interfaces were made for baseline patient characteristics, average hours of CPAP use, side effects from therapy, and among questionnaires evaluating patients' subjective responses to therapy at months 1 and 2.
                No significant difference was observed in the average hours of CPAP use between the oral (4.5+/-2.1; 5.5+/-2.6) and nasal groups (4.0+/-2.6; 4.8+/-2.5) for either month 1 or 2 (P>0.05). The dropout rates were similar for both groups after 8 weeks of therapy. However, patients in the nasal group had higher occurrences of side effects such as nasal congestion, dryness, and air leaks, whereas patients in the oral group experienced more oral dryness and gum pain.
                Oral delivery of CPAP with the Oracle is an effective and suitable alternative for patients with OSAHS. 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).
                Randomized, cross-over.
                Two suburban community-based hospital sleep laboratories.
                Data were collected on 39 patients with OSAHS (mean age, 48.7 years), in whom CPAP was a novel treatment.
                Interventions were nasal pillows (Breeze; Mallinckrodt Corporation; Minneapolis, MN) and nasal mask (Contour; Respironics; Murrysville, PA).
                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).
                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. Many patients with sleep apnoea/hypopnoea syndrome (SAHS) find nasal continuous positive airway pressure (CPAP) treatment unsatisfactory due to side effects related to mouth air leakage. A study was performed to compare side effects with face mask and nose mask CPAP therapy in patients with SAHS, with and without uvulopalatopharyngoplasty (U3P).
                Twenty newly diagnosed patients with SAHS took part in a randomised double limb trial of face or nose mask CPAP therapy (four weeks per limb) in which CPAP compliance in terms of machine run time was measured and patients answered a symptom questionnaire on side effects resulting from the mask. Ten patients with SAHS with U3P (SAHS/U3P) who were already regular users of nasal CPAP were also given a four week trial of face mask CPAP to compare compliance and symptoms. Ten patients with SAHS were matched with the 10 SAHS/U3P patients for body mass index, age, apnoea/hypopnoea index, and CPAP pressure. Long term compliance was estimated one year after the mask comparison studies.
                For patients with SAHS nightly compliance was higher with a nose mask (mean (SE) 5.3 (0.4) hours/night CPAP) than with a face mask (4.3 (0.5) hours/night CPAP), p = 0.01 (mean difference 1.0 hour/night, 95% CI 1.8 to 0.3). Nose masks were rated more comfortable by 19 of 20 patients (p < 0.001) despite more mouth leak related symptoms. For SAHS/U3P patients compliance was marginally higher with nose masks (5.1 (0.7) hours/night CPAP) than with face masks (4.0 (0.8) hours/night CPAP), p = 0.07 (mean difference 1.1 hour/night, 95% CI 2.1 to 0.1). Nose masks were rated more comfortable by seven of 10 patients. There were no significant differences in side effect scores with face and nose masks. At one year nine of 10 SAHS patients and nine of 10 SAHS/U3P patients were still using CPAP. Compliance was 5.4 (0.6) hours/night for the SAHS patients and 3.5 (0.4) hours/night for the SAHS/U3P patients, p = 0.02 (mean difference 1.9 hour/night, 95% CI 3.6 to 0.3).
                Compliance is greater with nose mask CPAP than with face mask CPAP because the overall comfort is better and compensates for increased symptoms associated with mouth leakage. Improved face mask design is needed. To assess separately the effectiveness and safety of nasal-continuous positive airway pressure (N-CPAP) and that of surgery in comparison to conservative management in patients with obstructive sleep apnea syndrome (OSAS). DESIGN. A randomized study with 1-year follow-up.
                A university hospital acting as a referral center for OSAS.
                Symptomatic patients with OSAS (72 male and 4 female patients aged 18 to 65 years), who had oxygen desaturations in the overnight recording.
                After the initial diagnostic workup, patients were considered to be candidates for either N-CPAP (44 patients) or surgical treatment (uvulopalatopharyngoplasty [UPPP] with or without mandibular osteotomy) (32 patients). Within the groups, the patients were then randomized to either the assigned treatment or conservative management.
                The number of nocturnal oxygen desaturation events of 4% or more per hour in bed (ODI4); daytime somnolence; side effects.
                N-CPAP Group: Compliance with N-CPAP therapy at 1 year was 13 of 21. The most common reason for noncompliance was general intolerance of CPAP. All compliant patients had a normal ODI4 ( < 10), whereas 1 of 20 of their control subjects had a normal finding. Patients receiving active treatment were significantly less somnolent than their control subjects at 1 year (p < 0.05). SURGERY GROUP: At 1 year, 7 of 18 of the surgically treated and 1 of 14 of the conservatively treated patients had a normal ODI4 (p < 0.001). Daytime somnolence was significantly less severe in the surgically treated patients compared with their control subjects (p < 0.001) both at 3 and 12 months. The overall postoperative complication rate was 22%.
                N-CPAP is an effective therapy for OSAS, but compliance is a problem. Surgical therapy (UPPP with or without mandibular osteotomy) needs further evaluation.
Due to the limited number of studies available comparing various interface types, he optimum form of CPAP delivery interface remains unclear. The results of our review suggest that nasal pillows or the Oracle oral mask may be useful alternatives when a patient is unable to tolerate conventional nasal masks. The face mask can not be recommended as a first line interface, but may be considered if nasal obstruction or dryness limits the use of a nasal mask. Further randomised studies comparing the different forms of CPAP delivery interface now available for the treatment of OSA, in larger groups of patients and for longer durations, are required.