Do dental parameters predict severity of obstructive sleep apnea and mandibular advancement device therapy outcomes? A pilot study.

BACKGROUND: Mandibular Advancement Devices (MAD's) are oral appliances commonly used in treatment of Obstructive Sleep Apnea (OSA). OSA severity and certain other factors, such as BMI and neck circumference, correlate with MAD therapy success. So far, the predictive value of dental parameters, such as dental profile, molar-classification, overjet, overbite, maximal retrusion, maximal protrusion and protrusive range, has not been fully investigated. OBJECTIVES: We aimed to investigate whether dental parameters influence OSA severity and MAD therapy outcome and could therefore be helpful in phenotyping OSA patients. Furthermore, we studied the predictive power of dental parameters for OSA severity and successful MAD therapy. We hypothesise that specific dental parameters correlate with more severe OSA and with more successful MAD treatment. METHODS: We performed a cohort study, including OSA patients diagnosed by polysomnography (PSG). Dental parameters were collected. Objective treatment outcome was collected by performing a PSG with MAD after three months of therapy. Differences between OSA severity groups and MAD treatment outcomes were analysed and dental parameters were correlated between groups. RESULTS: The relation between dental parameters and OSA severity was analysed in 143 patients, fifty patients had a PSG with MAD in situ after a 3-month therapy. The median baseline Apnea Hypopnea Index (AHI) significantly reduced from 17.6 (8.7-29.3) to 11.1 (5.5-17.5). Overbite and maximal retrusion differed significantly between mild, moderate and severe OSA. Other dental parameters did not differ significantly between the groups, nor correlated with OSA severity or MAD treatment outcome. CONCLUSION: In this study, no correlation between dental parameters and OSA severity or MAD treatment outcomes was found. Therefore, screening patients for OSA and MAD treatment outcome based on dental parameters is currently not possible.

Equal effect of a noncustom vs a custom mandibular advancement device in treatment of obstructive sleep apnea.

STUDY OBJECTIVES: Numerous types of mandibular advancement devices (MADs) are available to treat patients with obstructive sleep apnea, varying from noncustom to custom devices. Only a limited number of studies have been performed to determine whether a noncustom MAD could be used to predict treatment success of a custom MAD. In this study, we investigated the potential of a new-generation noncustom MAD, by comparing its effectiveness with a custom MAD. We hypothesized that the effectiveness of the devices is similar with regard to both objective (polysomnography) and self-reported (questionnaires, adherence, and patient satisfaction) outcomes. METHODS: This was a single-center prospective randomized crossover study including a consecutive series of patients with obstructive sleep apnea. Patients were randomized to start either with the noncustom or custom MAD. Both MADs were applied for 12 weeks, followed by polysomnography with MAD in situ and questionnaires. After the first 12 weeks of follow-up, a washout period of 1 week was applied. Equal effectiveness was defined as no significant differences in both objective and self-reported outcomes between both devices. RESULTS: Fifty-eight patients were included; 40 completed the full follow-up. The median apnea-hypopnea index significantly decreased from 16.3 (7.7, 24.8) events/h to 10.7 (5.6, 16.6) events/h with the custom MAD (P = .010) and to 7.8 (2.9, 16.1) events/h with the noncustom MAD (P < .001). Self-reported outcomes significantly improved in both groups. No significant differences were found between both devices. CONCLUSIONS: The effectiveness of a noncustom and custom MAD is comparable, which suggests that a noncustom MAD can be used as a selection tool for MAD treatment eligibility to improve MAD treatment outcome. CLINICAL TRIAL REGISTRATION: Registry: Netherlands Trial Register; Name: The Use of a Boil and Bite Mandibular Advancement Device vs a Custom Mandibular Advancement Device in Obstructive Sleep Apnea Management; URL: https://www.trialregister.nl/trial/7249; Identifier: NL64738.100.18. CITATION: Bosschieter PFN, Uniken Venema JAM, Vonk PE, et al. Equal effect of a noncustom vs a custom mandibular advancement device in treatment of obstructive sleep apnea. J Clin Sleep Med. 2022;18(9):2155-2165.

Cardiovascular and metabolic effects of a mandibular advancement device and continuous positive airway pressure in moderate obstructive sleep apnea: a randomized controlled trial.

STUDY OBJECTIVES: It has been suggested that treatment for obstructive sleep apnea (OSA) reduces cardiovascular risk. So far, knowledge is limited about the difference in the reduction of this risk between mandibular advancement device (MAD) and continuous positive airway pressure (CPAP) therapy. The aim of this study was to compare the cardiovascular effects of MAD vs CPAP therapy in patients with moderate OSA. METHODS: Patients with an apnea-hypopnea index of 15-30 events/h were randomized to either MAD or CPAP therapy. At baseline and after 12-month follow-up, 24-hour ambulant blood pressure measurements and laboratory measurements were performed. Ambulant blood pressure measurements consisted of 24-hour, daytime and night-time systolic and diastolic blood pressure and heart rate measurements. Laboratory measurements consisted of serum lipid values, creatinine, high-sensitivity C-reactive protein, plasma glucose, hemoglobin A1c glycated hemoglobin, proinflammatory cytokines, soluble receptor for advanced glycation end-products, chemokines, and adhesion molecules. RESULTS: Of the 85 randomized patients with moderate OSA, data were available for 54 patients (n = 24 MAD, n = 30 CPAP) at 12-month follow-up and showed that apnea-hypopnea index significantly decreased with either therapy. In the MAD group, soluble receptor for advanced glycation end-products and glycated hemoglobin were significantly higher after 12 months' follow-up compared to baseline. No significant changes were found between MAD and CPAP treatments for all outcomes. CONCLUSIONS: Treatment of patients with moderate OSA with either MAD or CPAP therapy had no profound effects on major cardiovascular risk factors after 12 months. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Title: MRA Therapy vs CPAP Therapy in Moderate OSAS; Identifier: NCT01588275; URL: https://clinicaltrials.gov/ct2/show/NCT01588275. CITATION: Uniken Venema JAM, Knol-de Vries GE, van Goor H, Westra J, Hoekema A, Wijkstra PJ. Cardiovascular and metabolic effects of a mandibular advancement device and continuous positive airway pressure in moderate obstructive sleep apnea: a randomized controlled trial. J Clin Sleep Med. 2022;18(6)1547-1555.

Mandibular advancement device design: A systematic review on outcomes in obstructive sleep apnea treatment.

Obstructive Sleep Apnea (OSA) is often treated with Mandibular Advancement Devices (MADs). It is unclear whether particular design features are superior to others in terms of OSA alleviation. In order to facilitate clinical decision-making, this systematic review summarizes the objective and subjective outcomes of different available MAD designs. Studies comparing different MAD designs in OSA treatment were searched. After screening 1887 titles and abstracts, 20 original RCTs and six cohort studies were included. 14 articles were systematically reviewed in a meta-analysis. The decrease in AHI was significantly different between some of the MAD designs. The clinical relevance of the observed differences was however limited. Monoblock appliances performed more favorable, compared to bilateral thrust (effect size:-0.37; CI:-1.81 to 0.07). Midline traction appliances performed more favorable, compared to other designs. Custom appliances performed more favorable, compared to thermoplastic appliances (effect size:0.86; CI:-0.62 to 2.35). Furthermore, there were no clinically relevant differences between MAD designs in reduction of ESS, compliance, preference, side effects, and cost effectiveness. With respect to the included trials, presently there is not one superior custom MAD design in OSA treatment regarding the effect on AHI reduction, ESS improvement, compliance, preference, side effects, cost effectiveness, and other disease-related outcomes. We confirm custom MAD designs perform superior to thermoplastic MAD designs.

Health outcomes of continuous positive airway pressure versus mandibular advancement device for the treatment of severe obstructive sleep apnea: an individual participant data meta-analysis.

STUDY OBJECTIVES: The impact of therapy with continuous positive airway pressure (CPAP) and mandibular advancement device (MAD) has not been directly compared in patients with severe obstructive sleep apnea (OSA). The purpose of this individual participant data meta-analysis was to compare the treatment effects of CPAP and titratable MAD on sleepiness, quality of life, sleep-disordered breathing severity, and sleep structure in patients with severe OSA. METHODS: Randomized controlled trials (RCTs) that included severe OSA patients were identified in order to compare the impact of the two treatments. Individual data from severe OSA patients were extracted from the databases and pooled for analysis. RESULTS: Of the seven studies identified, three crossover RCT and one parallel-group RCT corresponding to 151 patients and 249 observations (125 in the CPAP treatment arm and 124 in the MAD treatment arm) were included in the analysis. Titratable MAD had a similar impact to CPAP on major patient-centered outcomes (sleepiness and quality of life). CPAP was more effective in reducing AHI and ODI. However, the two treatments had a similar impact on sleep structure with an increase of N3 and REM sleep. Finally, treatment adherence and preference were largely in favor of MAD. CONCLUSION: This meta-analysis suggests that MAD represents an effective alternative treatment in severe OSA patients intolerant to CPAP or who prefer alternate therapy.

Jaw thrust versus the use of a boil-and-bite mandibular advancement device as a screening tool during drug-induced sleep endoscopy.

STUDY OBJECTIVES: The objectives of this study were to analyze agreement in degree of obstruction and configuration of the upper airway between jaw thrust and an oral device in situ during drug-induced sleep endoscopy and to evaluate clinical decision making using jaw thrust or a boil-and-bite mandibular advancement device (MAD; the MyTAP). METHODS: This was a single-center prospective cohort study in patients with obstructive sleep apnea who underwent drug-induced sleep endoscopy between January and July 2019. RESULTS: Sixty-three patients were included. Agreement among observations in the supine position for degree of obstruction was 60% (n = 36, κ = 0.41) at the level of the velum, 68.3% (n = 41, κ = 0.35) for oropharynx, 58.3% (n = 35, κ = 0.28) for tongue base, and 56.7% (n = 34, κ = 0.14) for epiglottis; agreement among observations in the lateral position were 81.7% (n = 49, κ = 0.32), 71.7% (n = 43, κ = 0.36), 90.0% (n = 54, κ = 0.23), and 96.7% (n = 58, κ = could not be determined), respectively. In the supine position, agreement for configuration of obstruction at the level of the velum was found in 20 of 29 patients (69.0%, κ = 0.41) and in the lateral position was 100%. Thirty patients would have been prescribed a MAD using jaw thrust and 34 using the boil-and-bite MAD as a screening instrument. The main reason for being labeled as nonsuitable was complete residual retropalatal collapse during jaw thrust. Using the boil-and-bite MAD, this was caused by complete retropalatal or hypopharyngeal collapse. CONCLUSIONS: There is only slight to moderate agreement in degree of obstruction for jaw thrust and a new-generation boil-and-bite MAD during drug-induced sleep endoscopy. Greater improvement of upper airway patency at the hypopharyngeal level was observed during jaw thrust, but this maneuver was less effective in improving upper airway obstruction at the retropalatal level.

Long-term obstructive sleep apnea therapy: a 10-year follow-up of mandibular advancement device and continuous positive airway pressure.

STUDY OBJECTIVES: Obstructive sleep apnea (OSA) is a sleep-related breathing disorder, commonly managed by either continuous positive airway pressure (CPAP) or a mandibular advancement device (MAD). Long-term follow-up and comparison regarding efficacy of these therapies is scarce. In this study the results of treatment, patient adherence, and satisfaction over a 10-year follow-up of these therapies are reported. METHODS: This is a longitudinal follow-up study taken from a subset of patients initially enrolled in a randomized controlled clinical trial of 103 patients with OSA (51 and 52 patients randomized for MAD and CPAP, respectively). After a 10-year follow-up period, 14 patients using MAD and 17 patients using CPAP could be evaluated for this longitudinal follow-up study. Data were analyzed at baseline, after 3 months and at 1-, 2-, and 10-year follow-up. All 31 patients with OSA underwent polysomnography and self-reported measurements. RESULTS: Polysomnography results showed a favorable outcome of both therapies at 10-year follow-up. At baseline, included patients in both groups did not significantly differ in apnea-hypopnea index (AHI) values. At 10-year follow-up, both the MAD and CPAP groups showed a significant reduction in AHI. At baseline the mean AHI in the MAD group was 31.7 ± 20.6 events/h whereas in the CPAP group it was 49.2 ± 26.1 events/h. At 10-year follow-up the mean AHI in the MAD group was 9.9 ± 10.3 events/h and in the CPAP group it was 3.4 ± 5.4 events/h. Both therapies resulted in a substantial improvement in self-reported neurobehavioral outcomes at 10-year follow-up. CONCLUSIONS: Both CPAP and MAD therapy demonstrate good and stable treatment effects after a 10-year follow-up period. Therefore, when indicated, both therapies are appropriate modalities for the long-term management of OSA. CLINICAL TRIAL REGISTRATION: Registry: Netherlands Trial Register; Name: Management of the Obstructive Sleep Apnea-Hypopnea Syndrome: Oral Appliance versus Continuous Positive Airway Pressure Therapy; Identifier: NL75; URL: https://www.trialregister.nl/trial/75.

Dental side effects of long-term obstructive sleep apnea therapy: a 10-year follow-up study.

OBJECTIVES: Patients with obstructive sleep apnea (OSA) are usually treated with either mandibular advancement device (MAD) or continuous positive airway pressure (CPAP) therapy. The objective of this study is to evaluate changes in dental occlusion associated with long-term MAD and CPAP therapy. MATERIALS AND METHODS: Data from 14 OSA patients using MAD and 17 OSA patients using CPAP therapy were evaluated at baseline, 2-year and 10-year follow-up. Changes in dental occlusion were analyzed from dental plaster casts with a digital sliding caliper. RESULTS: At 2-year follow-up, MAD therapy resulted in significant dental changes when compared with baseline values. In MAD therapy, overjet and overbite decreased with 1.1 ± 1.8 mm and 1.1 ± 1.2 mm respectively. With CPAP therapy overjet and overbite decreased significantly with 0.2 ± 0.5 mm and 0.3 ± 0.5 mm, respectively. Both groups also showed significant changes in molar occlusion. After a 10-year follow-up, significant and more pronounced changes were seen in overjet and overbite. In MAD therapy, overjet and overbite decreased with 3.5 ± 1.5 mm and 2.9 ± 1.5 mm respectively when compared with baseline values. In CPAP therapy, overjet and overbite decreased with 0.7 ± 1.5 mm and 0.8 ± 1.4 mm respectively when compared with baseline values. CONCLUSIONS: This study demonstrates that MAD and CPAP therapy result in significant changes in dental occlusion. These changes appear progressive and more pronounced with MAD compared to CPAP therapy. CLINICAL RELEVANCE: Long-term OSA treatment results in significant dental side effects that may progress over time. Informed consent is fundamental before starting MAD treatment and individualized long-term follow-up is of eminent importance.

Long-Term Objective Adherence to Mandibular Advancement Device Therapy Versus Continuous Positive Airway Pressure in Patients With Moderate Obstructive Sleep Apnea.

STUDY OBJECTIVES: Comparable health effects of mandibular advancement device (MAD) and continuous positive airway pressure (CPAP) therapy have been attributed to higher adherence with MAD compared with CPAP therapy. The objective of this study was to make a direct comparison of the objective adherence between MAD and CPAP in patients with moderate obstructive sleep apnea (OSA). METHODS: Adherence was monitored for 12 months in 59 patients with moderate OSA (apnea-hypopnea index 15-30 events/h) as part of a randomized controlled trial. Objective adherence with MAD was assessed using the TheraMon microsensor. Objective adherence with CPAP was assessed using the built-in registration software with readout on SD card. Self-reported adherence with both therapies was assessed using a questionnaire. RESULTS: Forty patients (68%) completed the study with the therapy to which they were randomly assigned. Median (interquartile range) objective adherence (h/night) in the 3rd month was 7.4 (5.2-8.2) for MAD and 6.8 (5.7-7.6) for CPAP (P = .41), compared to 6.9 (3.5-7.9) with MAD and 6.8 (5.2-7.6) with CPAP (P = .85) in the 12th month. There were no significant changes between the 3rd and 12th month for both MAD (P = .21) and CPAP (P = .46). Changes in adherence were not significantly different between MAD and CPAP (P = .51). Self-reported adherence was significantly higher with MAD than CPAP at all follow-ups. Self-reported adherence with CPAP was lower than objective CPAP adherence at the 6th and 12th month (P = .02). CONCLUSIONS: Objective adherence with MAD and CPAP is comparable and consistent over time. Self-reported adherence is higher with MAD than with CPAP giving rise to interesting discrepancy between objective and self-reported adherence with CPAP. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Identifier: NCT01588275.

Clinical- and Cost-Effectiveness of a Mandibular Advancement Device Versus Continuous Positive Airway Pressure in Moderate Obstructive Sleep Apnea.

STUDY OBJECTIVES: Limited evidence exists on the cost-effectiveness of mandibular advancement device (MAD) compared to continuous positive airway pressure (CPAP) therapy in moderate obstructive sleep apnea (OSA). Therefore, this study compares the clinical and cost-effectiveness of MAD therapy with CPAP therapy in moderate OSA. METHODS: In a multicentre randomized controlled trial, patients with an apnea-hypopnea index (AHI) of 15 to 30 events/h were randomized to either MAD or CPAP. Incremental cost-effectiveness and cost-utility ratios (ICER/ICUR, in terms of AHI reduction and quality-adjusted life-years [QALYs, based on the EuroQol Five-Dimension Quality of Life questionnaire]) were calculated after 12 months, all from a societal perspective. RESULTS: In the 85 randomized patients (n = 42 CPAP, n = 43 MAD), AHI reduction was significantly greater with CPAP (median reduction AHI 18.3 [14.8-22.6] events/h) than with MAD therapy (median reduction AHI 13.5 [8.5-18.4] events/h) after 12 months. Societal costs after 12 months were higher for MAD than for CPAP (mean difference €2.156). MAD was less cost-effective than CPAP after 12 months (ICER -€305 [-€3.003 to €1.572] per AHI point improvement). However, in terms of QALY, MAD performed better than CPAP after 12 months (€33.701 [-€191.106 to €562.271] per QALY gained). CONCLUSIONS: CPAP was more clinically effective (in terms of AHI reduction) and cost-effective than MAD. However, costs per QALY was better with MAD as compared to CPAP. Therefore, CPAP is the first-choice treatment option in moderate OSA and MAD may be a good alternative. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Identifier: NCT01588275.

Cardiovascular effects of oral appliance therapy in obstructive sleep apnea: A systematic review and meta-analysis.

Obstructive sleep apnea (OSA) is associated with increased cardiovascular morbidity and mortality. This study systematically reviews the effects of oral appliance therapy (OAT) on a broad spectrum of cardiovascular outcomes. A literature search was performed up to December 31st 2016. Twenty-five relevant full-text articles were retrieved. Sixteen articles were considered methodologically sufficient, including 11 randomized controlled trials. Pooled data of the RCTs showed significant reductions in daytime systolic and diastolic blood pressure compared to baseline, but no significant reductions in heart rate, except for daytime heart rate when compared to inactive/placebo OAT. OAT and continuous positive airway pressure (CPAP) were equally effective in reducing blood pressure. Studies assessing the effect of OAT on heart rate variability, circulating cardiovascular biomarkers, and endothelial function and arterial stiffness, generally involved small numbers of patients, and were heterogeneous and inconclusive. Studies assessing the effect of OAT on cardiac function showed no effects on echocardiographic outcomes. One observational study showed that OAT was as effective as CPAP in reducing cardiovascular death. It could be speculated that OAT may lead to a reduction in long-term cardiovascular morbidity and mortality in OSA patients. However, further methodologically high quality, longitudinal studies are warranted to address this key question.

Biomechanical effects of a mandibular advancement device on the temporomandibular joint.

PURPOSE: Mandibular advancement devices are commonly used in the treatment of patients with mild to moderate obstructive sleep apnea (OSA). Designed to maintain the mandible in forced protrusion while being worn, mandibular advancement devices (MADs) are intended to increase the upper airway during sleep, thereby reducing OSA symptoms. Depending on the extent of mandibular protrusion, side effects including temporomandibular joint dysfunction are frequently reported. These are likely to reduce overall treatment success by affecting therapeutic adherence. MATERIAL AND METHODS: To investigate the biomechanical effects of an MAD on the temporomandibular joints, we used a biomechanical model of the human masticatory system. Alterations to the model were applied to mimic the effects of a titratable duoblock MAD. The extent of mandibular protrusion was simulated up to 10 mm in steps of 1 mm. Compression and shear stresses on the temporomandibular structures were predicted during an open-close maneuver and in neutral position. RESULTS: As the extent of mandibular advancement increased, the mandibular condyle migrated anteriorly until passing the articular tubercle. Stress on the temporomandibular joint structures did not considerably increase in rest whatever the extent of mandibular advancement. However, closure of the jaw required extra muscle force as mandibular advancement increased. CONCLUSION: Results from this study suggest that temporomandibular dysfunction following MAD wearing might be related to altered muscle dynamics rather than changes due to increased stress in the temporomandibular joint itself.

Usage of positional therapy in adults with obstructive sleep apnea.

STUDY OBJECTIVES: Many positional therapy (PT) strategies are available for treating positional obstructive sleep apnea (OSA). PT is primarily supplied to selected patients as a secondary treatment option when other therapies have failed. To our knowledge this is the largest study to date to assess effectiveness and long-term compliance of PT (both commercial waistband and self-made constructions, mimicking the tennis ball technique) as primary treatment in patients with different positional OSA severities. METHODS: PT was used by 53 patients, of which 40 patients underwent a follow-up polygraphic evaluation under treatment after a median time interval of 12 weeks. Patients were routinely contacted regarding their clinical status and treatment compliance. RESULTS: PT was successful in 27 out of 40 patients (68%). Overall AHI reduced significantly from a median (interquartile range [IQR]) AHI of 14.5 (10.7-19.6) to 5.9 (3.1-8.5), p < 0.001. The commercial waistband and self-made constructions were equally effective (median (IQR) reduction in overall AHI (Δ9.6 (5.5-11.9) and Δ6.8 (3.2-11.3) respectively), p = 0.22). Short-term compliance was good as most patients used PT more than 7 hours/night (mean 7.2 ± SD 1.4) and more than 6 days/ week (mean 6.5 ± SD 1.3). However, after mean 13±5 months, 26 patients (65%) reported they no longer used PT, especially patients with moderate positional OSA (89%). CONCLUSIONS: On the short-term, PT using the tennis ball technique, is an easy method to treat most patients with positional OSA, showing significant reductions in AHI. Unfortunately, long-term compliance is low and close follow-up of patients on PT with regard to their compliance is necessary.

Maxillomandibular advancement surgery as alternative to continuous positive airway pressure in morbidly severe obstructive sleep apnea: a case report.

Obstructive sleep apnea syndrome (OSAS) is a sleep-related breathing disorder, characterized by disrupted snoring and repetitive upper airway obstructions. Oral appliance therapy is an effective alternative to continuous positive airway pressure (CPAP) and is especially effective in mild and moderate OSAS cases. Successful oral appliance therapy has been suggested as a predictor for successful maxillomandibular advancement (MMA) surgery in OSAS patients. MMA surgery has gained increasing popularity in this field since this procedure is associated with an enlargement of the entire velo-oro-hypopharyngeal airway. The authors present an unusual case of a CPAP-intolerant morbidly obese female (body mass index (BMI) = 40) with morbidly severe OSAS (apnea-hypopnea index (AHI) = 139, lowest oxyhemoglobin saturation level = 73%), who underwent a successful combination of MMA surgery, a modified genioplasty and cervicomental liposuction after oral appliance therapy. The post-surgical AHI was 6, and the lowest oxyhemoglobin saturation level increased to 86%. The authors suggest that this surgical combination should be seriously considered in obese patients with severe OSAS and CPAP intolerance.

Oral appliance versus continuous positive airway pressure in obstructive sleep apnea syndrome: a 2-year follow-up.

STUDY OBJECTIVES: Oral appliance therapy has emerged as an important alternative to continuous positive airway pressure (CPAP) in treating patients with obstructive sleep apnea syndrome (OSAS). In this study we report about the subjective and objective treatment outcome of oral appliance therapy and CPAP in patients with OSAS. DESIGN: Cohort study of a previously conducted randomized clinical trial. SETTING: University Medical Center, Groningen, The Netherlands. PATIENTS OR PARTICIPANTS: One hundred three patients with OSAS. INTERVENTIONS: CPAP and oral appliance therapy (Thornton Adjustable Positioner type-1, Airway Management, Inc., Dallas, TX, USA). MEASUREMENTS AND RESULTS: Objective (polysomnography) and subjective (Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, Medical Outcomes Study 36-item Short Form Health Survey [SF-36]) parameters were assessed after 1 and 2 years of treatment. Treatment was considered successful when the apnea-hypopnea index (AHI) was < 5 or showed substantial reduction, defined as reduction in the index of at least 50% from the baseline value to a value of < 20 in a patient without OSAS symptoms while undergoing therapy. Regarding the proportions of successful treatments, no significant difference was found between oral appliance therapy and CPAP in treating mild to severe OSAS in a 2-year follow-up. More patients (not significant) dropped out under oral appliance therapy (47%) compared with CPAP (33%). Both therapies showed substantial improvements in polysomnographic and neurobehavioral outcomes. However, CPAP was more effective in lowering the AHI and showed higher oxyhemoglobin saturation levels compared to oral appliance therapy (P < 0.05). CONCLUSIONS: Oral appliance therapy should be considered as a viable treatment alternative to continuous positive airway pressure (CPAP) in patients with mild to moderate obstructive sleep apnea syndrome (OSAS). In patients with severe OSAS, CPAP remains the treatment of first choice. CLINICAL TRIAL INFORMATION: The original randomized clinical trial, of which this study is a 2-year follow-up, is registered at ISRCTN.org; identifier: ISRCTN18174167; trial name: Management of the obstructive sleep apnea-hypopnea syndrome: oral appliance versus continuous positive airway pressure therapy; URL: http://www.controlled-trials.com/ISRCTN18174167.

Impaired driving simulation in patients with Periodic Limb Movement Disorder and patients with Obstructive Sleep Apnea Syndrome.

BACKGROUND: Excessive daytime sleepiness (EDS) is considered to be responsible for increased collision rate and impaired driving simulator performance in Obstructive Sleep Apnea Syndrome (OSAS) patients. Periodic Limb Movement Disorder (PLMD) patients also frequently report EDS and may also have impaired driving capacities. METHODS: PLMD patients (n=16), OSAS patients (n=18), and controls (n=16) performed a monotonous 25-min driving simulation task. Parameters for driving capacity were the slope of the standard deviation of the lane position, lapses of attention (LOA), and structural deviations. The severity of sleep disruption and the degree of subjective sleepiness were measured. RESULTS: Slope and LOA were significantly higher in patients than controls, pointing to a decreased driving performance. At start patients and controls had similar driving capacity. The PLMD and OSAS groups did not differ on any scale or simulation performance, although OSAS patients generally performed worse. Subjective sleepiness was higher in patients than controls, and correlated positively with driving simulator parameters. Severity of the disorder and performance were uncorrelated. CONCLUSION: PLMD and OSAS patients showed impaired performance in a simulated monotonous driving task. At start, patients and controls performed similarly, but patient performance decreased clearly with time, suggesting that decreased vigilance as a result of disturbed sleep is an important component of deteriorated simulated and, possibly, real driving performance.

Long-term oral appliance therapy in obstructive sleep apnea syndrome: a controlled study on temporomandibular side effects.

The objective of this study was to assess variations in the occurrence of temporomandibular disorders (TMDs) and the risk of developing pain and function impairment of the temporomandibular complex in obstructive sleep apnea syndrome (OSAS) patients treated with either an oral appliance (mandibular advancement device) or continuous positive airway pressure (CPAP) in a 2-year follow-up study. In addition, we assessed the relationship between the mean mandibular protrusion and the frequency of wearing the appliance during follow-up with the occurrence of pain and function impairment of the temporomandibular complex. Fifty-one patients were randomized to oral appliance therapy and 52 patients to CPAP therapy. TMDs (diagnosed according to the Axis I Research Diagnostic Criteria for TMD), pain intensity and disability and mandibular function impairment were recorded at baseline, after 2 months, 1 year and 2 years of therapy. Only in the initial period of treatment the occurrence of pain-related TMDs was considerably higher (24%) in the oral appliance group compared to CPAP (6%). Oral appliance therapy furthermore resulted in more temporomandibular pain compared to CPAP (odds ratio 2.33, 95% confidence interval (1.22-4.43)). However, there were no limitations in mandibular function in both groups during the (entire) follow-up period. Although generally not serious and of transient nature, oral appliance therapy results in more pain-related TMDs in the initial period of use compared with CPAP therapy. Oral appliance therapy is associated with increased pain in the temporomandibular complex in the initial period of use. Because of the transient nature, this pain is not a reason to contra-indicate an oral appliance in OSAS patients. Moreover, TMDs and the risk of developing pain and function impairment of the temporomandibular complex appear limited with long-term oral appliance use.

Effects of oral appliances and CPAP on the left ventricle and natriuretic peptides.

BACKGROUND: In patients without cardiac disease, obstructive sleep apnea-hypopnea syndrome (OSAHS) is associated with systolic and diastolic dysfunction and left ventricular hypertrophy. Although continuous positive airway pressure (CPAP) therapy has been demonstrated to improve left ventricular structure and function in these patients, the effects of oral-appliance therapy on cardiac function are largely unknown. The aims of this study were to determine the left ventricular structure and function and natriuretic peptides in untreated OSAHS patients without cardiovascular disease, and to compare the effects of oral-appliance with CPAP therapy. METHODS: In 28 moderate to severe OSAHS patients echocardiography and measurements of concentrations of the amino-terminal fragment of pro-brain natriuretic peptide (NT-pro-BNP) were performed. Fifteen patients were randomized to oral-appliance and 13 to CPAP therapy. After 2 to 3 months of treatment echocardiography and NT-pro-BNP measurements were repeated. RESULTS: Of the 28 patients, 7 had left ventricular hypertrophy, 6 had left ventricular dilatation, and 3 had elevated NT-pro-BNP values. No significant improvements in echocardiographic outcomes were observed following treatment. The median NT-pro-BNP values improved significantly following oral-appliance therapy (52 pg/ml to 22 pg/ml) whereas not following CPAP therapy (31 pg/ml to 37 pg/ml). CONCLUSIONS: This study demonstrates that 50% of patients with moderate to severe OSASH, without cardiovascular disease, have left ventricular hypertrophy, left ventricular dilatation or elevated natriuretic peptides. Significant changes in NT-pro-BNP values indicate an improvement of cardiac function following effective oral-appliance therapy.

Implant-retained oral appliances: a novel treatment for edentulous patients with obstructive sleep apnea-hypopnea syndrome.

OBJECTIVES: Mandibular repositioning appliances (MRAs) are a viable treatment alternative in patients with obstructive sleep apnea-hypopnea syndrome (OSAHS). Because these appliances require retention in the patient's dentition, edentelous patients generally do not qualify for this treatment. This study describes our experiences with an implant-retained MRA in the treatment of edentulous OSAHS patients. PATIENTS AND METHODS: Six edentulous OSAHS patients were included in this study. Standard treatment consisted of the placement of four endosseous dental implants in the mandible and the construction of a new maxillary denture and a mandibular overdenture. Subsequently, an MRA was made. After a habituation and adjustment period, the effect of treatment was evaluated with polysomnography. Treatment was considered effective in cases where it yielded an apnea-hypopnea index <5. RESULTS: Of the six patients included, two did not tolerate the MRA because of pressure-induced discomfort on the labial mucosa in the maxilla. These two patients were offered an implant-retained overdenture and MRA in the maxilla. One of the two patients proceeded with this secondary treatment. Of the five patients completing the follow-up polysomnography, effective OSAHS treatment was attained in four. CONCLUSIONS: The results from this study suggest that an implant-retained MRA in the mandible is a viable treatment modality in edentulous OSAHS patients. Because the therapeutic effectiveness of this treatment may be compromised by excessive pressure of the MRA on the labial mucosa in the maxilla, we suggest that an implant-retained MRA in the maxilla be offered as a secondary treatment in selected patients.

Craniofacial, craniocervical, and pharyngeal morphology in bilateral cleft lip and palate and obstructive sleep apnea patients.

OBJECTIVE: The aim of this study was to analyze craniofacial, craniocervical, and pharyngeal morphology in surgically treated bilateral cleft lip and palate (BCLP) men, untreated men with obstructive sleep apnea (OSA), and a reference group of men. SUBJECTS AND METHODS: Lateral cephalograms were obtained of 27 male BCLP patients (mean age 29.0 +/- 8.3 years), 27 untreated male OSA patients (mean age 38.6 +/- 5.3 years), and 27 male controls serving as a reference group (mean age 30.8 +/- 9.2 years). Tracings were made, and 26 variables representing craniofacial, craniocervical, and pharyngeal dimensions were obtained using Viewbox 3.1.1.6. software. The groups were compared using a one-way analysis of variance. RESULTS: Craniofacial, craniocervical, and pharyngeal morphology of BCLP and OSA patients was similar except for a significantly more retrusive maxilla in the BCLP group. Compared to the reference group, the BCLP and OSA groups had significantly larger craniocervical angulations, smaller depth of the oropharynx at the tip of the velum, and a more inferiorly positioned hyoid bone. Significantly larger vertical dimensions were found in the BCLP group compared to the reference group. CONCLUSIONS: Craniofacial, craniocervical, and pharyngeal morphology of BCLP and OSA patients demonstrate substantial similarities except for a significantly more retrusive maxilla in the BCLP group. It is suggested that airway obstruction and postural adaptation to the obstruction may possibly be related to the aberrant craniofacial, craniocervical, and pharyngeal morphology in OSA and in BCLP patients.