Multimodal phenotypic labelling using drug-induced sleep endoscopy, awake nasendoscopy and computational fluid dynamics for the prediction of mandibular advancement device treatment outcome: a prospective study.

Mandibular advancement device (MAD) treatment outcome for obstructive sleep apnea (OSA) is variable and patient dependent. A global, clinically applicable predictive model is lacking. Our aim was to combine characteristics obtained during drug-induced sleep endoscopy (DISE), awake nasendoscopy, and computed tomography scan-based computational fluid dynamic (CFD) measurements in one multifactorial model, to explain MAD treatment outcome. A total of 100 patients with OSA were prospectively recruited and treated with a MAD at fixed 75% protrusion. In all, 72 underwent CFD analysis, DISE, and awake nasendoscopy at baseline in a blinded fashion and completed a 3-month follow-up polysomnography with a MAD. Treatment response was defined as a reduction in the apnea-hypopnea index (AHI) of ≥50% and deterioration as an increase of ≥10% during MAD treatment. To cope with missing data, multiple imputation with predictive mean matching was used. Multivariate logistic regression, adjusting for body mass index and baseline AHI, was used to combine all potential predictor variables. The strongest impact concerning odds ratios (ORs) was present for complete concentric palatal collapse (CCCp) during DISE on deterioration (OR 28.88, 95% confidence interval [CI] 1.18-704.35; p = 0.0391), followed by a C-shape versus an oval shape of the soft palate during wakefulness (OR 8.54, 95% CI 1.09-67.23; p = 0.0416) and tongue base collapse during DISE on response (OR 3.29, 95% CI 1.02-10.64; p = 0.0464). Both logistic regression models exhibited excellent and fair predictive accuracy. Our findings suggest DISE to be the most robust examination associated with MAD treatment outcome, with tongue base collapse as a predictor for successful MAD treatment and CCCp as an adverse DISE phenotype.

A promising concept of combination therapy for positional obstructive sleep apnea.

PURPOSE: The objective of this randomized controlled trial was to assess the additional effect of a chest-worn sleep position trainer (SPT) in patients with residual supine-dependent obstructive sleep apnea (sdOSA) under mandibular advancement device (MAD) therapy. METHODS: Baseline and follow-up polysomnography with MAD were performed. Twenty patients with sdOSA under MAD therapy underwent two consecutive randomized polysomnographies: one with SPT and one with combination of SPT + MAD. Data are presented as median (quartile 1, quartile 3). RESULTS: The SPT reduced the time spent in supine sleeping position compared to baseline and MAD therapy. Both MAD and SPT were individually effective in reducing the overall apnea/hypopnea index (AHI) significantly when compared to baseline from 20.8 (15.1; 33.6)/h at baseline to 11.0 (6.7; 13.8)/h and to 11.1 (3.5; 17.7)/h with MAD or SPT, respectively. The combination of SPT + MAD further reduced the overall AHI to 5.7 (3.6; 7.4), which was significantly lower than with MAD alone (p < 0.001) and SPT alone (p < 0.008), respectively. CONCLUSIONS: The results of this study indicate that combination of SPT + MAD leads to a higher therapeutic efficacy in patients with sdOSA under MAD therapy when compared to one of the treatment modalities alone.

The relationship between specific nasopharyngoscopic features and treatment deterioration with mandibular advancement devices: a prospective study.

STUDY OBJECTIVES: The variable efficacy of mandibular advancement device (MAD) treatment necessitates both accessible and accurate methods for patient selection. However, the role of awake nasopharyngoscopy for this purpose remains dubious. We introduced an assessment method based on anatomical upper airway features during tidal breathing for nasopharyngoscopy. The current study aimed to relate these features to MAD treatment outcome. METHODS: One hundred patients diagnosed with obstructive sleep apnea were prospectively recruited for MAD treatment in a fixed 75% degree of maximal protrusion. Nasopharyngoscopic observations during Müller's maneuver and tidal breathing were recorded both with and without MAD. Treatment outcome, confirmed by 3-month follow-up polysomnography with MAD, was classified as (1) apnea-hypopnea index reduction ≥ 50%, (2) treatment apnea-hypopnea index < 5 events/h, and (3) ≥ 10% increase in apnea-hypopnea index compared with baseline (treatment deterioration). RESULTS: A complete dataset was obtained in 65 patients. After adjusting for baseline apnea-hypopnea index, body mass index, and supine dependency, the position of the soft palate (odds ratio, 4.0; 95% confidence interval, 1.3-11.8; P = .013) and crowding of the oropharynx (odds ratio, 7.7; 95% confidence interval, 1.4-41.4; P = .017) were related to treatment deterioration. Addition of both features significantly (P = .031) improved the accuracy of baseline models based on clinical measurements alone. Moreover, with the MAD in situ, a posteriorly located soft palate (odds ratio, 9.8; 95% confidence interval, 1.7-56.3; P = .010) and a posteriorly located tongue base (odds ratio, 7.4; 95% confidence interval, 1.5-35.9; P = .013) were associated with treatment deterioration. CONCLUSIONS: Awake nasopharyngoscopy might be a valuable office-based examination to exclude the risk of treatment deterioration and improve patient selection for MAD treatment. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea (PROMAD); URL: https://clinicaltrials.gov/ct2/show/NCT01532050; Identifier: NCT01532050.

Phenotypic Labelling Using Drug-Induced Sleep Endoscopy Improves Patient Selection for Mandibular Advancement Device Outcome: A Prospective Study.

STUDY OBJECTIVES: Mandibular advancement device (MAD) outcome varies between patients. We hypothesized that upper airway collapse sites, patterns, and degrees assessed during baseline drug-induced sleep endoscopy (DISE) affect MAD outcome. METHODS: One hundred patients with obstructive sleep apnea (OSA) were included and underwent baseline type 1 polysomnography. MAD was fitted intraorally at fixed 75% maximal protrusion. A total of 72 patients completed 3-month follow-up polysomnography and baseline DISE. Response was defined as apnea-hypopnea index (AHI) reduction ≥ 50%, deterioration as AHI increases during MAD treatment compared to baseline. RESULTS: Adjusting for baseline AHI and body mass index, patients with tongue base collapse showed 3.69 higher odds (1.27-10.73; P = .0128) for response. Complete concentric collapse at the level of the palate (5.32 [1.21-23.28]; P = .0234) and complete laterolateral oropharyngeal collapse (6.62 [1.14-38.34]; P = .0330) related to deterioration. Results for tongue base collapse and complete concentric collapse at the level of the palate were confirmed in the moderate to severe OSA subgroup. Applying these results to this selected subgroup increased response rate with 54% and decreased deterioration rate with 53%. These results were confirmed using other response and deterioration definitions. CONCLUSIONS: Three baseline DISE phenotypes identified during drug-induced sleep were significantly related to MAD treatment outcome: one beneficial, tongue base collapse, and two adverse, complete concentric collapse at the level of the palate and complete laterolateral oropharyngeal collapse. If confirmed in future prospective studies, these results could guide patient selection for MAD outcome. CLINICAL TRIAL REGISTRATION: This prospective clinical trial (PROMAD) was registered on Clinicaltrials.gov with identifier: NCT01532050. CITATION: Op de Beeck S, Dieltjens M, Verbruggen AE, Vroegop AV, Wouters K, Hamans E, Willemen M, Verbraecken J, De Backer WA, Van de Heyning PH, Braem MJ, Vanderveken OM. Phenotypic labelling using drug-induced sleep endoscopy improves patient selection for mandibular advancement device outcome: a prospective study. J Clin Sleep Med. 2019;15(8):1089-1099.

Determinants of Objective Compliance During Oral Appliance Therapy in Patients With Sleep-Disordered Breathing: A Prospective Clinical Trial.

IMPORTANCE: The main reported reasons for discontinuation of oral appliance therapy for sleep-disordered breathing (SDB) are the presence of self-perceived adverse effects and self-appreciated lack of efficacy. However, these conclusions rely only on subjective compliance data. OBJECTIVE: To determine which parameters are correlated with objectively measured data on compliance with oral appliance therapy. DESIGN, SETTING, AND PARTICIPANTS: For 51 outpatients with SDB, a prospective clinical trial using oral appliance therapy was conducted at Antwerp University Hospital from February 7, 2011, to October 8, 2013 (38 [75%] males; mean [SD] age, 49.3 [9.0] years; mean [SD] apnea-hypopnea index, 14.9 [9.3] events per hour of sleep; mean [SD] body mass index [calculated as weight in kilograms divided by height in meters squared], 26.3 [2.8]). Analysis was performed November 5, 2014. INTERVENTION: Oral appliance therapy with a custom-made, titratrable mandibular advancement device (OAm). MAIN OUTCOMES AND MEASURES: Possible correlations were assessed between objective compliance and patients' anthropometric characteristics, polysomnographic parameters, and answers to 3 subjective questionnaires (the visual analog scale for snoring, the Epworth Sleepiness Scale, and an adverse effects questionnaire). RESULTS: Median oral appliance use was 6.4 hours per night (range, 4.7-7.2 hours per night) at the 3-month follow-up. None of the anthropometric and polysomnographic parameters were correlated with compliance. No correlation was found between objective compliance and reports of excessive daytime sleepiness. However, a significant inverse correlation was found between objective compliance and posttreatment visual analog scale values for snoring (P = .006; ρ = ­.40). In addition, objective compliance was correlated significantly with a more pronounced decrease in socially disturbing snoring (P = .005; ρ = 0.39). The presence of dry mouth was the only adverse effect that was negatively correlated with objective compliance at the 3-month follow-up (P < .05; ρ = ­.31). CONCLUSIONS AND RELEVANCE: Neither the anthropometric and polysomnographic parameters nor reports of excessive daytime sleepiness correlated with compliance during oral appliance therapy. The 2 parameters that were correlated with higher objective compliance during oral appliance therapy were a more pronounced decrease in snoring and the presence of dry mouth during treatment. TRIAL REGISTRATION: clinicaltrials.gov Identifiers: NCT01284881 and NCT01532050.