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. Nasal versus full face mask for noninvasive ventilation in chronic respiratory failure. A randomized crossover efficacy trial of oral CPAP (Oracle) compared with nasal CPAP in the management of obstructive sleep apnea. Continuous versus bilevel positive airway pressure for obstructive sleep apnea. A long-term randomized, cross-over comparison of auto-titrating and standard nasal continuous airway pressure. A randomized crossover study of an oral appliance vs nasal-continuous positive airway pressure in the treatment of mild-moderate obstructive sleep apnea.
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. This study was undertaken to determine the efficacy of nasal mask (NM) versus full face mask (FFM) for the delivery of noninvasive ventilation (NIV) in subjects with nocturnal hypoventilation. A total of 16 patients (11 males) were enrolled, all with nocturnal hypoventilation currently treated at home with NIV via pressure preset devices. Subjects underwent full polysomnography on three occasions; on the first night current therapy on NM was reviewed, followed by two experimental studies in randomised order using either NM or FFM. NIV settings and oxygen flow rate were the same under both conditions. Notably, 14 of the 16 subjects required the use of a chinstrap to minimise oral leak. Apnoea-hypopnoea indices were within normal limits under both conditions (1.7 +/- 3.4 NM versus 1.6 +/- 2.4 h FFM). The type of interface did not significantly affect gas exchange during sleep (minimum average arterial oxyhaemoglobin saturation total sleep time 93.4 +/- 2.1 NM versus 92.8 +/- 2.5% FFM, Delta transcutaneous carbon dioxide nonrapid eye movement sleep to rapid eye movement sleep (0.58 +/- 0.36 NM versus 0.50 +/- 0.40 kPa FFM). Sleep efficiency was significantly reduced on the FFM (78 +/- 9 NM versus 70 +/- 14% FFM), although arousal indices were comparable under both conditions (15.6 +/- 9.8 NM versus 15.8 +/- 8.8 h FFM). Full face masks appear to be as effective as nasal masks in the delivery of noninvasive ventilation to patients with nocturnal hypoventilation. However, a chinstrap was required to reduce oral leak in the majority of subjects using the nasal mask. To determine the therapeutic efficacy and viability of a novel oral interface for continuous positive airway pressure (CPAP) compared with conventional nasal interfaces.
                A randomized single-blind crossover study.
                Hospital-based sleep laboratory.
                21 CPAP-naïve patients with obstructive sleep apnea (baseline apnea-hypopnea index, 85 +/- 36) Interventions: Nasal CPAP and oral CPAP MEASUREMENTS AND RESULTS: Patients were each treated for two 4-week periods using nasal CPAP and oral CPAP. The CPAP titrations were undertaken at the start of each treatment arm. Outcome measures were recorded at baseline and at the end of each treatment arm. These included polysomnography variables, CPAP compliance, subjective sleepiness, obstructive sleep apnea symptom ratings, and adverse effects. There were no significant differences between oral and nasal interfaces for the on-CPAP frequency of apneas and hypopneas (mean difference, nasal-oral [95%CI] = -4.6[-10.1-1.0]/h; P = 0.06) or arousals (-3.0 [-7.8-1.8]/h; P = 0.23). There were also no statistically significant differences between interfaces for scores on the Epworth Sleepiness Scale (-0.7 [-3.1-1.7]; P = 0.20), obstructive sleep apnea symptoms (-7.7 [-17.7-2.4]; P = 0.052), CPAP compliance (0.3 [-0.5-1.1] h/night; P = 0.50), CPAP pressure (0.05 [-0.66-0.76] cmH20; P = 0.73), CPAP side effects scores (-2.0 [-5.3-1.4]; P = 0.23), or mask preference (P = 0.407). In addition, both nasal and oral interfaces significantly improved polysomnographic variables, Epworth Sleepiness Scale scores, obstructive sleep apnea symptoms, and CPAP compliance from baseline (all P < 0.05).
                This preliminary study indicates that oral CPAP has similar efficacy to traditionally applied nasal CPAP in treating obstructive sleep apnea. Additional large studies are required to determine the range of clinical situations where oral CPAP is indicated. Recent objective studies demonstrate relatively low hours of nightly use during nasal continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea (OSA). Patients frequently complain of dyspnea or discomfort during CPAP use, especially during expiration (against the continuous pressure), which may be a reason for the low hours of use. We hypothesized that with decreased expiratory pressure, hours of nightly use would increase. Therefore, we randomized 83 OSA patients to receive either continuous or bilevel positive airway pressure when expiratory pressure is lower. To document objectively the effective use of either therapy, we built and installed elapsed-time and mask pressure sensors in the patients' positive airway pressure units. A total of 62 patients were evaluable and followed for 1 yr. Of these, 26 received bilevel and 36 CPAP pressures. The machine timers measured accumulated "machine-on" time, and the mask pressure sensor recorded the total time in which the mask pressure was within 2 cm H2O of the effective pressure (pressure shown to eliminate 95% of the obstructive apneas during a full night of polysomnography). The mean machine timer hours of CPAP were 5.0 +/- 0.19 SEM and 4.9 +/- 0.23 SEM during bilevel therapy (p NS) over a 12-mo period. The pressures required during CPAP or bilevel therapy were not different between high and low hourly users. Effective use, the percentage of time that the machine was running and the prescribed pressure was being delivered, was 80% in CPAP and 82% in the bilevel users (p NS). Both groups had equal complaints with regard to mask discomfort, machine noise, and nasal stuffiness.(ABSTRACT TRUNCATED AT 250 WORDS) This study is a 12-week randomized, cross-over, single-blind comparison of the tolerance, compliance, and symptomatic improvement obtained with standard nasal continuous positive airway pressure (CPAP) vs. an auto-titrating, self-adjusting device (APAP). Sixty newly diagnosed patients, 53 with obstructive sleep apnea (OSA) and seven with upper airway resistance syndrome were studied. Thirty-nine patients (65%) completed the 24-week protocol. Data were complete in 33. In these 33 patients CPAP and APAP reduced the Epworth Sleepiness score from 15+/-1 (+/-SEM) to 8+/-1 and 9+/-1 respectively (both <0.0001 from baseline but NS between modes). The APAP average pressure was lower than the CPAP pressure, 6.4+/-0.4 and 10.6+/-0.4 cm H20, respectively. The average daily machine use was greater with APAP, 6.0+/-0.3 hrs. versus 5.5+/-0.3 hrs. with CPAP (P < 0.04). The number of days of machine use, and the pattern of use were not different between CPAP and APAP. A higher proportion of patients who did not complete the study was randomized to CPAP for their initial treatment period. This study showed that: 1) CPAP and APAP produced an equivalent improvement in daytime sleepiness, 2) APAP pressure was lower than CPAP pressure, 3) patients wore the APAP device longer during nights they used the pressure support system, and 4) patients who began the study with APAP were more prone to continue treatment. We conclude that APAP was better tolerated and used a greater number of hours than CPAP, but the extent of improvement in excessive daytime sleepiness was similar between the two modes of therapy. To compare efficacy, side effects, patient compliance, and preference between oral appliance (OA) therapy and nasal-continuous positive airway pressure (N-CPAP) therapy.
                Randomized, prospective, crossover study.
                University hospital and tertiary sleep referral center.
                Twenty-seven unselected patients with mild-moderate obstructive sleep apnea (OSA).
                There was a 2-week wash-in and a 2-week wash-out period, and 2 x 4-month treatment periods (OA and N-CPAP). Efficacy, side effects, compliance, and preference were evaluated by a questionnaire and home sleep monitoring.
                Two patients dropped out early in the study and treatment results are presented on the remaining 25 patients. The apnea/hypopnea index was lower with N-CPAP (3.5 +/- 1.6) (mean +/- SD) than with the OA (9.7 +/- 7.3) (p < 0.05). Twelve of the 25 patients who used the OA (48%) were treatment successes (reduction of apnea/hypopnea to <10/h and relief of symptoms), 6 (24%) were compliance failures (unable or unwilling to use the treatment), and 7 (28%) were treatment failures (failure to reduce apnea/hypopnea index to <10/h and/or failure to relieve symptoms). Four people refused to use N-CPAP after using the OA. Thirteen of the 21 patients who used N-CPAP were overall treatment successes (62%), 8 were compliance failures (38%), and there were no treatment failures. Side effects were more common and the patients were less satisfied with N-CPAP (p < 0.005). Seven patients were treatment successes with both treatments, six of these patients preferred OA, and one preferred N-CPAP as a long-term treatment.
                We conclude that OA is an effective treatment in some patients with mild-moderate OSA and is associated with fewer side effects and greater patient satisfaction than N-CPAP.
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.