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

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

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