Aarnoud Hoekema

Efficacy and co-morbidity of oral appliances in the treatment of obstructive sleep apnea-hypopnea: A systematic review

The Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS) is a common sleep-related breathing disorder characterized by repetitive obstructions of the upper airway during sleep. Modification of pharyngeal patency by Oral Appliance (OA) therapy has been suggested as an alternative to various treatment modalities for OSAHS. To determine the evidence base with respect to the efficacy and co-morbidity of OA therapy in OSAHS, we conducted a systematic review of the available literature. Primary outcome measures were the reduction in number of upper-airway obstructions and co-morbidity related to the craniomandibular or craniofacial complex, respectively. Eligible studies regarding efficacy were independently assessed by two assessors using a quality assessment scale. Effect sizes of methodologically sound studies were calculated. In identical interventions, effect sizes were pooled with the use of a random-effects model. Given the scarcity of controlled studies related to co-morbidity, appraisal was confined to a description of eligible studies. Sixteen controlled trials related to efficacy were identified. With respect to the primary outcome measure, OA therapy was clearly more effective than control therapy (pooled effect size, -0.96; 95% confidence interval [CI], -1.49 to -0.42) and possibly more effective than uvulopalatopharyngoplasty. Although patients generally preferred OA therapy, improvement of respiratory variables, such as the number of upper-airway obstructions, was usually better in Continuous Positive Airway Pressure (CPAP) therapy (pooled effect size, 0.83; 95% CI, 0.59 to 1.06). Moreover, specific aspects related to OA design may influence patient-perceived efficacy and preference. Twelve patient-series and one controlled trial related to co-morbidity were identified. Analysis of the data suggests that OA therapy may have adverse effects on the craniomandibular and craniofacial complex. Although CPAP is apparently more effective and adverse effects of OA treatment have been described, it can be concluded that OA therapy is a viable treatment for, especially, mild to moderate OSAHS. Controlled studies addressing the specific indication and co-morbidity of OA therapy are warranted.

Obstructive Sleep apnea Therapy

In clinical practice, oral appliances are used primarily for obstructive sleep apnea patients who do not respond to continuous positive airway pressure (CPAP) therapy. We hypothesized that an oral appliance is not inferior to CPAP in treating obstructive sleep apnea effectively. We randomly assigned 103 individuals to oral-appliance or CPAP therapy. Polysomnography after 8–12 weeks indicated that treatment was effective for 39 of 51 persons using the oral appliance (76.5%) and for 43 of 52 persons using CPAP (82.7%). For the difference in effectiveness, a 95% two-sided confidence interval was calculated. Non-inferiority of oral-appliance therapy was considered to be established when the lower boundary of this interval exceeded −25%. The lower boundary of the confidence interval was −21.7%, indicating that oral-appliance therapy was not inferior to CPAP for effective treatment of obstructive sleep apnea. However, subgroup analysis revealed that oral-appliance therapy was less effective in individuals with severe disease (apnea-hypopnea index > 30). Since these people could be at particular cardiovascular risk, primary oral-appliance therapy appears to be supported only for those with non-severe apnea.

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.

Predictors of Obstructive Sleep Apnea-Hypopnea Treatment Outcome

Oral appliance therapy is an alternative to continuous positive airway pressure (CPAP) for treating the obstructive sleep apnea-hypopnea syndrome. However, the ability to pre-select suitable candidates for either treatment is limited. The aim of this study was to assess the value of relevant variables that can predict the outcome of oral appliance and CPAP therapy. Fifty-one patients treated with oral appliance therapy and 52 patients treated with CPAP were included. Relevant clinical, polysomnographic, and cephalometric variables were determined at baseline. The predictive value of variables for treatment outcome was evaluated in univariate and multivariate analyses. The outcome of oral appliance therapy was favorable, especially in less obese patients with milder sleep apnea and with certain craniofacial characteristics (mandibular retrognathism in particular). Neither univariate nor multivariate analyses yielded variables that reliably predicted the outcome of CPAP. We conclude that the variables found in this study are valuable for pre-selecting suitable candidates for oral-appliance therapy.

Long-term oral-appliance therapy in obstructive sleep apnea: a cephalometric study of craniofacial changes.

OBJECTIVES The aim of this randomized controlled study was to cephalometrically assess possible changes in craniofacial morphology associated with long-term use of an adjustable oral-appliance compared with continuous positive airway pressure (CPAP) in patients with the obstructive sleep apnea/hypopnea syndrome (OSAHS). In addition, we wanted to study the relationship between these possible changes and the degree of mandibular protrusion associated with oral-appliance therapy. METHODS Fifty-one patients were randomized to oral-appliance therapy and 52 patients to CPAP therapy. At baseline and after follow-up (2.3±0.2 years), a lateral cephalogram of all patients was made in maximum intercuspation to determine relevant cephalometric variables. Both baseline and follow-up cephalograms were traced digitally whereupon cephalometric variables were compared. Changes in craniofacial morphology between the oral-appliance- and CPAP group were evaluated with a linear regression analysis. RESULTS Compared with CPAP, long-term use of an oral-appliance resulted in small but significant (dental) changes. Overbite and overjet decreased, 1.0 (±1.5)mm and 1.7 (±1.6)mm, respectively. Furthermore we found a retroclination (-2.0 (±2.8)°) of the upper incisors and a proclination (3.7 (±5.4)°) of the lower incisors. Moreover, the lower- and total anterior facial height increased significantly, 0.8 (±1.5)mm and 0.9 (±1.4)mm, respectively. No changes in skeletal variables were found. Linear regression analysis revealed that the decrease in overbite was associated with the mean mandibular protrusion during follow-up (B=-0.029, SE=0.014, p<0.05). CONCLUSIONS Oral-appliance therapy should be considered as a life long treatment, and there is a risk of craniofacial changes to occur. Therefore, patients treated with an oral-appliance, need a thorough follow-up by a dentist or dental-specialist experienced in the field of dental sleep medicine.

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.

Efficacy and comorbidity of oral appliances in the treatment of obstructive sleep apnea-hypopnea : a systematic review and preliminary results of a randomized trial

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.

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.

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.

Maxillomandibular Advancement Surgery as Alternative to Continuous Positive Airway Pressure in Morbidly Severe Obstructive Sleep Apnea: A Case Report

Abstract 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.