Efficacy of positive airway pressure and oral appliance in mild to moderate obstructive sleep apnea. A randomized crossover study of an oral appliance vs nasal-continuous positive airway pressure in the treatment of mild-moderate obstructive sleep apnea. Efficacy and comorbidity of oral appliances in the treatment of obstructive sleep apnea-hypopnea: a systematic review and preliminary results of a randomized trial. Prospective evaluation of an oral appliance in the treatment of obstructive sleep apnea syndrome. Mandibular advancement splints and continuous positive airway pressure in patients with obstructive sleep apnoea: a randomized cross-over trial. Effects and adverse events of a dental appliance for treatment of obstructive sleep apnoea. Randomised study of three non-surgical treatments in mild to moderate obstructive sleep apnoea. Mandibular advancement appliances and obstructive sleep apnoea: a randomized clinical trial. Comparison of two dental devices for treatment of obstructive sleep apnea syndrome (OSAS). Oral appliance therapy improves symptoms in obstructive sleep apnea: a randomized, controlled trial. An individually adjustable oral appliance vs continuous positive airway pressure in mild-to-moderate obstructive sleep apnea syndrome. Randomized crossover trial of two treatments for sleep apnea/hypopnea syndrome: continuous positive airway pressure and mandibular repositioning splint.
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. 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. The obstructive sleep apnea-hypopnea syndrome (OSAHS) is a common sleep-related breathing disorder characterized by repetitive obstructions of the upper airway during sleep. The modification of pharyngeal patency by oral appliance therapy has been suggested as an alternative to various treatment modalities for OSAHS. To determine the evidence base with respect to the efficacy and comorbidity of the oral appliance therapy in OSAHS, a systematic review of the available literature was conducted. In addition, the preliminary results of a randomized parallel trial are reported on the effectiveness and specific indication of, respectively, the oral appliance and continuous positive airways pressure therapy in OSAHS. 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. This prospective, randomized, cross-over trial was designed to compare the efficacy of a mandibular advancement splint (MAS) with that of nasal continuous positive airway pressure (nCPAP) in patients with obstructive sleep apnoea (OSA). Twenty-four patients (20 males and four females) with mild to moderate OSA (AHI between 10 and 49 events per hour) were enrolled in the study. Each patient used both MAS and nCPAP, with the initial therapy being allocated at random. Treatment periods lasted for two months with a two-week wash-out interval between. Polysomnography was performed prior to the study and after each clinical intervention. Patient and partner questionnaires were used to assess changes in general health and daytime somnolence. The AHI decreased from 22.2 to 3.1 using nCPAP, and to 8.0 using the MAS (P < 0.001 for both devices) and there was no statistically significant difference between the two treatments. The Epworth Sleepiness Score (ESS) fell from 13.4 to 8.1 with nCPAP, and to 9.2 with MAS (P < 0.001), again with no differences between the use of MAS or nCPAP. The questionnaire data showed an improvement in general health scores (P < 0.001) after both treatments, but daytime sleepiness only improved significantly using nCPAP (P < 0.001). Despite this, 17 out of the 21 subjects who completed both arms of the study preferred the MAS. The splints were well tolerated and their efficacy suggests that the MAS may be a suitable alternative to nCPAP in the management of patients with mild or moderate OSA. 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. 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. This randomized placebo-controlled cross-over trial assessed the effectiveness of a mandibular advancement appliance (MAA) in managing obstructive sleep apnoea (OSA). Twenty-one adults, with confirmed OSA, were provided with a maxillary placebo appliance and a MAA for 4-6 weeks each, in a randomized order. Questionnaires at baseline and after each appliance assessed bed-partners' reports of snoring severity (loudness and number of nights per week), and patients' daytime sleepiness (Epworth Sleepiness Score, ESS). The Apnoea Hypopnoea Index (AHI) and Oxygen Desaturation Index (ODI) were measured at baseline and with each appliance during single night sleep studies. Seventy-nine per cent of subjects wore their MAA for at least 4 hours at night. Sixty-eight per cent of subjects wore their MAA for 6-7 nights per week. Excessive salivation was the most commonly reported complication. One subject was unable to tolerate the MAA and withdrew from the study. Among the remaining 20 subjects, the MAA produced significantly lower AHI and ODI values than the placebo. However, although the reported frequency and loudness of snoring and the ESS values were lower with the MAA than the placebo, these differences were not statistically significant. When wearing the MAA, 35 per cent of the OSA subjects had a reduction in the pre-treatment ODI to 10 or less, while 33 per cent had an AHI of 10 or less. The MAA was less effective in the subjects with the most severe OSA (pre-treatment ODI > 50 and/or pre-treatment AHI > 50). Previous case reports have indicated dental devices can be an effective nonsurgical treatment for snoring and obstructive sleep apnea. This pilot study evaluated the effectiveness of two intraoral devices in reducing the Respiratory Disturbance Index (RDI) and Epworth Sleepiness Scale (ESS) scores in a group of 24 adult volunteers with a history of loud snoring. Subjects were randomly assigned to two groups. Twelve subjects were fitted with a dental device designed to increase vertical dimension and protrude the mandible (device A). The other 12 subjects received a different device designed to minimally increase vertical opening without protruding the mandible (device B). Unattended home sleep monitoring (Edentrace II Digital Recorder, Edentech Corp.) was used to compute RDI at two time periods: (T0) before using any dental device and (T1) while using a dental device 2 weeks after the initial delivery date. The mean RDI and ESS scores at T0 for subjects in the device A group were 35.6 +/- 28.4 and 12.0 +/- 3.9, respectively. Means for the same measures at T1 were 21.1 +/- 21.4 and 8.2 +/- 4.0. For subjects in the device B group, means for RDI and ESS scores at T0 were 36.5 +/- 43.7 and 13.0 +/- 4.5, the means at T1 were 46.8 +/- 47.0 and 12.5 +/- 5.7. The effectiveness of the two devices was estimated by comparing the difference in RDI scores from T0 to T1 for the 10 subjects who were using device A and completed the study and the 8 subjects who were using device B and completed the study. Six subjects withdrew for various reasons. From T0 to T1, device A reduced RDI scores in 9 of 10 subjects, with a mean reduction in RDI of 14.5 (p < or = 0.05) and in ESS score of 3.8 (p < or = 0.005). Device B showed no change or an increased RDI score in 8 of 8 subjects. Seven of the eight subjects who showed no improvement in RDI with device B were then fitted with device A. Four of these seven subjects showed a reduction in RDI and five showed a reduction in ESS after using device A for 2 weeks. The mean reduction in RDI and ESS was 2.4 +/- 19.8 and 2.4 +/- 3.0, respectively. Hence, we conclude that a dental device that advances the mandible and increases the vertical dimension to open the upper airway is more effective in reducing the number of apneic and snoring events during sleep than one which does not. The aim of this study was to evaluate the effect of a mandibular advancement splint (MAS) on daytime sleepiness and a range of other symptoms in obstructive sleep apnea (OSA). Using a randomized crossover design, patients received 4 weeks of treatment with MAS and a control device (inactive oral appliance), with an intervening 1-week washout. At the end of each treatment period, patients were reassessed by questionnaire, polysomnography, and multiple sleep latency test. Fifty-nine men and 14 women with a mean (+/- SD) age of 48 +/- 11 years and proven OSA experienced a significantly improved mean (+/- SEM) sleep latency on the multiple sleep latency test (10.3 +/- 0.5 versus 9.1 +/- 0.5 minutes, p = 0.01) and Epworth sleepiness scale score (7 +/- 1 versus 9 +/- 1, p < 0.0001) with the MAS compared with the control device after 4 weeks. The proportion of patients with normal subjective sleepiness was significantly higher with the MAS than with the control device (82 versus 62%, p < 0.01), but this was not so for objective sleepiness (48 versus 34%, p = 0.08). Other OSA symptoms were controlled in significantly more patients with the MAS than with the control device. MAS therapy improves a range of symptoms associated with OSA. For the treatment of nonsevere obstructive sleep apnea syndrome (OSAS), mandibular advancement devices (MADs) are employed as an alternative to nasal continuous positive airway pressure (CPAP) therapy. However, very few specific data on the effectiveness of MADs in this group of patients are available. We therefore compared an individually adjustable intraoral sleep apnea device (ISAD) that permits movements of the lower jaw in three dimensions, with CPAP in the treatment of patients with an apnea/hypopnea index (AHI) < or = 30/h.
                In a randomized crossover study, 16 men and 4 women (mean +/- SD age, 56.5 +/- 10.2 years; body mass index, 31.2 +/- 6.4; AHI, 17.5 +/- 7.7/h) were treated for 6 weeks with each modality.
                In the initial phase, a significant improvement in AHI (baseline, 17.5 +/- 7.7/h; ISAD, 10.5 +/- 7.5/h [p < 0.05]; CPAP, 3.5 +/- 2.9/h [p < 0.01]) and in breathing-related arousals (baseline, 8.9 +/- 6.1/h; ISAD, 3.7 +/- 3.3/h [p < 0.01]; CPAP, 1.4 +/- 1.6/h [p < 0.01]) was achieved with both modalities. Considering all 20 subjects, after 6 weeks of treatment, normalization of the respiratory parameters was seen only with CPAP. However, 30% of the patients had a lasting reduction in AHI to < 10/h with the ISAD also. The patients considered the ISAD to be easier to use (scale of 1 to 6: ISAD, 1.8 +/- 1.1; CPAP, 3.1 +/- 1.5 [p < 0.05]), and indicated greater utilization of the device in comparison with CPAP.
                Even in patients with mild-to-moderate OSAS, CPAP is the more effective long-term treatment modality. In the individual case, the better compliance seen with the ISAD may be advantageous. Mandibular repositioning splints (MRSs) and continuous positive airway pressure (CPAP) are used to treat the sleep apnea/hypopnea syndrome (SAHS). There are some data suggesting that patients with milder symptoms prefer MRS, but there are few comparative data on outcomes. Therefore, we performed a randomized crossover trial of 8 weeks of CPAP and 8 weeks of MRS treatment in consecutive new outpatients diagnosed with SAHS (apnea/hypopnea index [AHI] >or= 5/hour, and >or= 2 symptoms including sleepiness). Assessments at the end of both limbs comprised home sleep study, subjective ratings of treatment value, sleepiness, symptoms, and well-being, and objective tests of sleepiness and cognition. Forty-eight of 51 recruited patients completed the trial (12 women; age [mean +/- SD], 46 +/- 9 years; Epworth 14 +/- 4; median AHI, 22/hour; interquartile ratio [IQR], 11-43/hour). Significant (p <or= 0.01) differences between MRS and CPAP were observed for 7 of 21 variables (effect sizes, 0.3-0.6 SDs), all favoring CPAP, including AHI (15 +/- 16 and 8 +/- 6/hour, respectively), effectiveness rating, symptoms, Epworth (12 +/- 5 and 8 +/- 5, respectively), functional outcomes of sleepiness questionnaire, short-form 36 health survey mental component, and health transition scores. Objective sleepiness, cognitive performance, and preference for treatments were not different. In patients experiencing a mild form of the syndrome (AHI < 15, n = 18), symptoms, treatment efficacy and satisfaction, and subjective sleepiness were also better with CPAP than with MRS (effect sizes, 0.7-1.1 SDs). These results do not support these MRS devices as first-line treatment for sleepy patients with SAHS.
There is increasing evidence suggesting that OA improves subjective sleepiness and sleep disordered breathing compared with a control. CPAP appears to be more effective in improving sleep disordered breathing than OA. The difference in symptomatic response between these two treatments is not significant, although it is not possible to exclude an effect in favour of either therapy. Until there is more definitive evidence on the effectiveness of OA in relation to CPAP, with regard to symptoms and long-term complications, it would appear to be appropriate to recommend OA therapy to patients with mild symptomatic OSAH, and those patients who are unwilling or unable to tolerate CPAP therapy. Future research should recruit patients with more severe symptoms of sleepiness, to establish whether the response to therapy differs between subgroups in terms of quality of life, symptoms and persistence with usage. Long-term data on cardiovascular health are required.