An interim oral appliance as a screening tool during drug-induced sleep endoscopy to predict treatment success with a mandibular advancement device for obstructive sleep apnea.

PURPOSE: Previous studies have shown a wide range of efficacy (29 to 71%) of a mandibular advancement device (MAD) in the treatment of obstructive sleep apnea (OSA). Currently, the ability to preselect suitable patients for MAD therapy based on individual characteristics related to upper airway collapsibility is limited. We investigated if the use of non-custom interim MAD during drug-induced sleep endoscopy (DISE) could be a valuable screening tool to predict MAD treatment outcome. METHODS: In a single-center prospective study including a consecutive series of patients with OSA, we compared DISE outcomes with a MAD in situ with polysomnography results after 3 months of using the same MAD that was used during DISE. RESULTS: Of 41 patients who completed the study, the median apnea-hypopnea index (AHI) was 16.0 events/h [IQR 7.4-23.4]. Respiratory outcomes on polysomnography, including apnea index (AI), total AHI, AHI in supine position, and oxygen desaturation index, all significantly improved after 3 months of MAD treatment. With complete improvement of the upper airway obstruction with the MAD in situ during DISE in supine position, patients were 6.3 times more likely to be a responder to MAD treatment compared to patients with a persisting complete obstruction, although not statistically significant (OR 6.3; 95%CI 0.9-42.7; p = 0.060). CONCLUSION: The potential predictive value with regard to MAD therapy outcomes of the use of an interim MAD during DISE would be an important finding, since the prediction of MAD therapy outcome is of great clinical and scientific interest. A study with a larger cohort should be performed to further investigate our findings.

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.

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.