A short-term controlled trial of an adjustable oral appliance for the treatment of mild to moderate obstructive sleep apnoea. Nasal-CPAP, surgery, and conservative management for treatment of obstructive sleep apnea syndrome. A randomized study. Health utilities in evaluating intervention in the sleep apnoea/hypopnoea syndrome. Randomised study of three non-surgical treatments in mild to moderate obstructive sleep apnoea. Effects and adverse events of a dental appliance for treatment of obstructive sleep apnoea. Intranasal budesonide treatment for children with mild obstructive sleep apnea syndrome. Radiofrequency vs laser in the management of mild to moderate obstructive sleep apnoea: does the number of treatment sessions matter? Randomised placebo controlled trial of daytime function after continuous positive airway pressure (CPAP) therapy for the sleep apnoea/hypopnoea syndrome. Clinical outcomes related to interface type in patients with obstructive sleep apnea/hypopnea syndrome who are using continuous positive airway pressure. Simple interventions improve re-attendance when treating the sleep apnoea syndrome. Efficacy of positive airway pressure and oral appliance in mild to moderate obstructive sleep apnea. Prospective evaluation of an oral appliance in the treatment of obstructive sleep apnea syndrome.
Although oral appliances are effective in some patients with obstructive sleep apnoea (OSA), they are not universally effective. A novel anterior mandibular positioner (AMP) has been developed with an adjustable hinge that allows progressive advancement of the mandible. The objective of this prospective crossover study was to compare efficacy, side effects, patient compliance, and preference between AMP and nasal continuous positive airway pressure (nCPAP) in patients with symptomatic mild to moderate OSA.
                Twenty four patients of mean (SD) age 44.0 (10.6) years were recruited with a mean (SD) body mass index of 32.0 (8.2) kg/m2, Epworth sleepiness score 10.7 (3.4), and apnoea/hypopnoea index 26.8 (11.9)/hour. There was a two week wash-in and a two week wash-out period and two treatment periods (AMP and nCPAP) each of four months. Efficacy, side effects, compliance, and preference were evaluated by a questionnaire and home sleep monitoring.
                One patient dropped out early in the study and three refused to cross over so treatment results are presented on the remaining 20 patients. The apnoea/hypopnoea index (AHI) was lower with nasal CPAP 4.2 (2.2)/hour than with the AMP 13.6 (14.5)/hour (p < 0.01). Eleven of the 20 patients (55%) who used the AMP were treatment successes (reduction of AHI to < 10/hour and relief of symptoms), one (5%) was a compliance failure (unable or unwilling to use the treatment), and eight (40%) were treatment failures (failure to reduce AHI to < 10/hour and/or failure to relieve symptoms). Fourteen of the 20 patients (70%) who used nCPAP were treatment successes, six (30%) were compliance failures, and there were no treatment failures. There was greater patient satisfaction with the AMP (p < 0.01) than with nCPAP but no difference in reported side effects or compliance.
                AMP is an effective treatment in some patients with mild to moderate OSA and is associated with greater patient satisfaction than nCPAP. 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. Formulating a rational health policy necessitates the ability to compare between different healthcare interventions and disease scenarios. Continuous positive airway pressure (CPAP) therapy with a conservative lifestyle strategy in sleep apnoea/hypopnoea syndrome (SAHS) was evaluated using health utility and quality-adjusted life years (QALYs) as outcome measures. A total 71 SAHS (apnoea/hypopnoea index > or = 15 h(-1)) patients completed a randomised, parallel group study over 3 months using utilities derived by the standard gamble approach (Usg) and European quality of life questionnaire (Euroqol) (Ueq). The severely impaired health status at baseline improved by 23% (Usg 0.32 to 0.55) adding 8 QALYs in the CPAP group, compared to a 4% improvement with 4.7 QALYs added in the lifestyle group (Usg 0.31 to 0.35). The Ueq showed a marginal change with CPAP (0.73 to 0.77) but did not demonstrate any improvement with lifestyle intervention. The health status impairment in sleep apnoea/hypopnoea syndrome patients is markedly improved by continuous positive airway pressure compared to a modest improvement with conservative lifestyle strategies using the standard gamble utility, which may be incorporated in effectiveness and economic analyses. The European quality of life questionnaire did not reflect a similar degree of impact and is probably not useful in this population. Patients with mild to moderate obstructive sleep apnoea (OSA) may be managed with different treatment options. This study compared the effectiveness of three commonly used non-surgical treatment modalities.
                Subjects with mild to moderate OSA were randomised to one of three treatment groups for 10 weeks: conservative measures (sleep hygiene) only, continuous positive airways pressure (CPAP) in addition to conservative measures or an oral appliance in addition to conservative measures. All overweight subjects were referred to a weight-reduction class. OSA was assessed by polysomnography. Blood pressure was recorded in the morning and evening in the sleep laboratory. Daytime sleepiness was assessed with the Epworth Sleepiness Scale. Health-related quality of life (HRQOL) was assessed with the 36-Item Short-Form Health Survey (SF-36) and Sleep Apnoea Quality of Life Index (SAQLI).
                101 subjects with a mean (SEM) apnoea-hypopnoea index (AHI) of 21.4 (1.1) were randomised to one of the three groups. The severity of sleep-disordered breathing was decreased in the CPAP and oral appliance groups compared with the conservative measures group, and the CPAP group was significantly better than the oral appliance group. Relief from sleepiness was significantly better in the CPAP group. CPAP was also better than the oral appliance or conservative measures in improving the "bodily pain" domain, and better than conservative measures in improving the "physical function" domain of SF-36. Both CPAP and the oral appliance were more effective than conservative measures in improving the SAQLI, although no difference was detected between the CPAP and oral appliance groups. CPAP and the oral appliance significantly lowered the morning diastolic blood pressure compared with baseline values, but there was no difference in the changes in blood pressure between the groups. There was also a linear relationship between the changes in AHI and body weight.
                CPAP produced the best improvement in terms of physiological, symptomatic and HRQOL measures, while the oral appliance was slightly less effective. Weight loss, if achieved, resulted in an improvement in sleep parameters, but weight control alone was not uniformly effective. In a prospective study, 95 patients with mild to moderate obstructive sleep apnoea (OSA) were randomised to receive either surgical treatment, uvulopalatopharyngoplasty, (4-6 patients) or treatment with a nocturnal dental appliance for mandibular advancement (49 patients). Of the 49 dental appliance patients, 37 completed the 12-month follow-up. The aim of this study was to evaluate the effects and adverse events of dental appliance treatment from a one-year perspective. Somnography was employed to measure treatment effects before and 12 months post-treatment. At the 12-month control, somnography was performed twice: the first time with the dental appliance and the second time without it. Adverse events were recorded 2 weeks and 3, 6, and 12 months after treatment was initiated. The patients used the dental appliance on average 6 nights/week. After 12 months of treatment, the apnoea, apnoea/hypopnoea, oxygen desaturation, and snoring indices decreased significantly. Ninety-five per cent of the patients reduced their apnoea index by > or = 50% and 78% of the patients were normalised following treatment. At the somnographic registration without the dental appliance, the values were found comparable to what they were before treatment. Mandibular mobility and occlusion were constant throughout the study. The adverse events resulting from using the dental appliance were relatively minor and infrequent, and no serious complications were observed except for two patients who reported pain from the temporomandibular joint. In conclusion, the dental appliance has been shown to be a valuable treatment method for mild to moderate OSA with few adverse events in the stomatognathic system or other complications. Intranasal corticosteroids have been advanced as a nonsurgical therapeutic alternative for pediatric obstructive sleep apnea syndrome, particularly for patients with mild disease, and aims at reducing the size of hypertrophic adenotonsillar tissue.
                Of 71 possible candidates, 62 children with polysomnographically diagnosed mild obstructive sleep apnea syndrome were recruited onto a double-blind, randomized, crossover trial of intranasal budesonide (32 microg per nostril at bedtime) or placebo for 6 weeks followed by an additional 6-week treatment in the alternative treatment arm after allowing for a 2-week washout period. Polysomnographic assessment and radiographs for assessment of adenoid size were performed after completion of each phase.
                There were significant improvements in both polysomnographic measures (sleep latency, slow-wave sleep, and rapid-eye-movement sleep), in the magnitude of respiratory disturbance (apnea/hypopnea index, nadir pulse oxygen saturation), and in adenoid size among the 48 children who completed the treatment phase compared with 32 children who received placebo in their initial arm, with normalization of sleep measures in 54.1% of the treated children. Furthermore, discontinuation of treatment for 8 weeks for 25 children revealed a sustained duration of the initial treatment effect.
                A 6-week treatment with intranasal budesonide effectively reduced the severity of mild obstructive sleep apnea syndrome and the magnitude of the underlying adenoidal hypertrophy, and this effect persisted for at least 8 weeks after cessation of therapy. These findings justify the use of topical steroids as the initial therapeutic option in otherwise healthy children with mild obstructive sleep apnea. Obstructive sleep apnea (OSA) is a relatively common and serious problem with many medical and social consequences. Laser and radiofrequency are two recent techniques used to treat OSA and they can be carried out under local anaesthesia, but they need multiple sessions to achieve satisfactory outcome and are associated with better short-term than long-term outcomes. In this work we compare the two modalities as regards the optimal number of treatment sessions needed to achieve a favourable outcome in the short and long term.
                A total of 150 patients with apnoea hypopnoea index (AHI) between 5 and 30 events per hour, no morbid obesity and retropalatal site of obstruction were included in this prospective study.
                Patients were randomly and equally divided into two groups, each comprising 75 patients. The first group was treated with bipolar radiofrequency volumetric tissue reduction of the palate (BRVTR) and the second group was treated with laser-assisted uvulopalatoplasty (LAUP). Each group was further subdivided into five subgroups each consisting of 15 patients. The first group received one treatment session, the second received two sessions, the third received three sessions, the fourth received four sessions and the fifth group received five treatment sessions. Evaluation of efficiency of both techniques in treating OSA was assessed objectively by polysomnography.
                In those treated with BRVTR; at least three sessions were needed to achieve a favourable outcome in OSA in the short and long term. In those treated with LAUP, a single treatment session was enough to achieve a favourable outcome on OSA in the short term, while two sessions were needed to achieve the same long-term outcome.
                In OSA, fewer treatment sessions are needed with LAUP (one session) than with BRVTR (three sessions) to achieve a favourable outcome. In LAUP more treatment sessions (two) are needed to maintain a longer-term favourable outcome than those needed to achieve short-term favourable outcome (one session), which is not the case with BRVTR (three sessions are needed to achieve both short- and long-term favourable results). Patients with the sleep apnoea/hypopnoea syndrome (SAHS) report improved sleepiness, cognitive function, and psychological well being after continuous positive airway pressure (CPAP) therapy, and it is for these daytime features that CPAP is usually given. However, few randomised or controlled studies exist on the effects of CPAP on daytime function.
                A prospective, randomised, single blind, placebo controlled, crossover trial of daytime function after CPAP was conducted in 23 patients with SAHS, all with > or = 15 apnoeas + hypopnoeas/hour and > or = 2 symptoms of SAHS. All patients spent four weeks on CPAP therapy and four weeks on oral placebo treatment, following randomisation to treatment order. With ethics committee approval, patients were told the placebo tablet might improve upper airway function. Average effective CPAP use was monitored using hidden time clocks. Assessments of objective and subjective sleepiness, symptoms, cognitive performance, and psychological well being were performed on the last day of each treatment and compared.
                Objective sleepiness measured by sleep onset latency on the multiple sleep latency test improved with CPAP (mean difference from placebo +2.4 min, 95% CI 0.8 to 4.0; p < 0.001) as did subjective sleepiness on the Epworth scale (mean difference -6, 95% CI -3 to -9; p = 0.001). Symptom total score also fell with CPAP (mean difference -1.6, 95% CI -2.2 to -1.0; p < 0.001). No determinants of these changes with active treatment were identified, and no significant enhancements to cognitive function or psychosocial well being were found in this small sample.
                These findings provide further evidence for clinically significant benefits to daytime function from CPAP. 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. Interventions to improve treatment outcomes in sleep apnoea-hypopnoea syndrome (SAHS) have had mixed success. Most have concentrated on following the use of a continuous positive airway pressure (CPAP) machines; poorer users may not return for machine readings, so any compliance study must take into account rates of attendance rates. We hypothesised that a series of additional, early support measures would improve re-attendance over a sustained period.
                Prospective, single-blinded interventional study. Seventy-two consecutive patients starting CPAP for SAHS were randomised to receive standard follow-up or extra early support. Attendance rates, CPAP use, Epworth scores, side-effects scores and number of changes to equipment were compared, by intent to treat, in both groups at 1 and 12 months.
                Re-attendance rates were higher in the intervention group at 1 month (P=0.04), 6 months (P=0.07) and 12 months (P=0.12). Those who defaulted tended previously to be poor users of the CPAP machine. For those who re-attended there was no difference in machine use or other outcomes.
                Simple interventions while commencing CPAP improve re-attendance with maximal benefit early on. This could provide more opportunities for solving problems early or considering alternative treatments. By confirming that poorer CPAP users eventually have higher default rates we recommend that future studies on CPAP compliance should first account for re-attendance rates. The efficacy of currently recommended treatments is uncertain in patients with mild to moderate obstructive sleep apnea (apnea-hypopnea index [AHI], 5-30). A group of 114 sleep clinic patients with an AHI of 5-30 have participated in a randomized controlled crossover trial of 3 months of treatment with each of nasal continuous positive airway pressure (CPAP), a mandibular advancement splint, and a placebo tablet. Outcomes were sleep fragmentation and hypoxemia, daytime sleepiness, quality of life, neurobehavioral function, and blood pressure. Both active treatments improved sleep outcomes, but positive airway pressure had a greater effect. The quality of life, symptoms, and subjective but not objective sleepiness improved to a similar degree with both treatments; however, many of the improvements seen in neuropsychologic function and mood were not better than the placebo effect. Some aspects of nocturnal blood pressure were improved with the splint but not with CPAP. This study has shown that although both CPAP and mandibular advancement splint effectively treated sleep-disordered breathing and sleepiness, the expected response in neurobehavioral function was incomplete. This may be due to the splint having a lesser therapeutic effect and CPAP being poorly tolerated and therefore used less in this patient group. The purpose of this study was to investigate the effects of an oral appliance (OA), with and without mandible advance, in the treatment of obstructive sleep apnea syndrome (OSA). Twenty-four patients diagnosed with OSA agreed to participate in this study. The patients were treated for 3 months (with a removable soft elastic silicone positioner customized with thermoplastic silicone and with a 5-mm opening). Patients were selected, using a randomized design, to receive an OA model either with (12 patients) or without advance (12 patients). Before treatment, a snoring questionnaire, the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), the Functional Outcomes of Sleep Questionnaire (FOSQ), the Epworth Sleepiness Scale (ESS), and polysomnography were completed. Fifteen subjects completed the protocol (13 men, two women). With respect to basal values, the mandible-advanced OA group presented a decrease in the mean apnea-hypopnea index (AHI) (33.8+/-4.7 versus 9.6+/-2.1; p<0.01), number of arousals per hour (33.8+/-13.9 versus 16.0+/-1.5; p<0.05), ESS score (14.7+/-5.1 versus 5.1+/-1.9; p<0.05), snoring score (15.4+/-1.9 versus 10.1+/-3.2; p<0.05), and total FOSQ score (78.1+/-22.6 versus 99.3+/-14.4; p<0.05). After treatment, the non-advanced group presented a decrease in the mean AHI (24.0+/-12.2 versus. 11.7+/-7.9; p<0.05). However, no significant differences were found in the number of arousals per hour, ESS score, snoring, and total FOSQ score in the non-advanced group. Neither study group showed significant difference in mean SF36 scores. Oral appliances, especially those that advance the mandible, offer an effective treatment for OSA.
There are now a small number of trials assessing different surgical techniques with inactive and active control treatments. The studies assembled in the review have failed to demonstrate consistent effects in favour of surgery and do not provide convincing evidence to support its use in sleep apnoea/hypopnoea syndrome. Short-term outcomes are unlikely to consistently identify suitable candidates for surgery. Long-term follow-up of patients who undergo surgical correction of upper airway obstruction is required. This would help to determine whether surgery is a curative intervention, or whether there is a tendency for the signs and symptoms of sleep apnoea to re-assert themselves, prompting patients to seek further treatment for sleep apnoea.