Marijke Dieltjens

Objective measurement of compliance during oral appliance therapy for sleep-disordered breathing

Background Oral appliance (OA) therapy is increasingly prescribed as a non-continuous positive airway pressure treatment modality for sleep-disordered breathing (SDB). Although OA therapy is reported to be efficacious for the treatment of SDB, data on compliance remain limited to self-report. Methods In this 3-month prospective clinical trial, the main outcome was to assess the safety and feasibility of an objective measurement of compliance during OA therapy using an embedded microsensor thermometer with on-chip integrated readout electronics in 51 consecutive patients with an established diagnosis of SDB (AHI 18.0±11.9/h; age 47±10 y; BMI 26.6±4.0 kg/m2; men/women: 31/20). Patients were unaware of the purpose of the study. Results No microsensor-related adverse events were recorded. In addition, no problems were encountered during the readout of the compliance data. Out of 51 microsensors, one had a technical defect and was lost to follow-up. In this study, the overall objective mean rate of OA use was 6.6±1.3 h per day with a regular OA users’ rate of 82% at the 3-month follow-up. Statistical analysis revealed no significant differences between objective and self-reported OA compliance data in this study. Measurement of the objective OA compliance allowed us to calculate the mean disease alleviation (MDA) as the product of objective compliance and therapeutic efficacy. MDA serves as a measure of the overall therapeutic effectiveness, and turned out to be 51.1%. Conclusions The results illustrate the safety and feasibility of objective measurement of OA compliance. The objective measurement of OA compliance allows for calculation of the MDA.

Sleep endoscopy with simulation bite for prediction of oral appliance treatment outcome

The aim of this study was to assess the value of drug‐induced sleep endoscopy (DISE) using a custom‐made simulation bite in maximal comfortable protrusion (MCP) of the mandible, in the prediction of treatment outcome for obstructive sleep apnea (OSA) with a mandibular advancement device (MAD). Two hundred patients (74% male; age 46 ± 9 years; apnea–hypopnea index [AHI] 19 ± 13 h−1 sleep; body mass index [BMI] 27 ± 4 kg m−2) with sleep‐disordered breathing underwent DISE with a simulation bite in MCP. One hundred and thirty‐five patients with an established diagnosis of OSA commenced MAD treatment. The associations between the findings during DISE with simulation bite and treatment outcome were evaluated. Treatment response was defined as a reduction in AHI following MAD treatment of ≥ 50% compared to baseline. Overall MAD treatment response in the studied population was 69%. The results of this study demonstrated a statistically significant association between a positive effect of the simulation bite on the upper airway patency during DISE and treatment response with MAD (P < 0.01). The results of this study suggest that the use of a simulation bite in maximal comfortable protrusion (MCP) of the mandible, as used during DISE in patients with OSA, tends to be effective in predicting treatment response of MAD treatment.

A promising concept of combination therapy for positional obstructive sleep apnea

PurposeThe 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.MethodsBaseline 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).ResultsThe 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.ConclusionsThe 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.

Objectively measured vs. self-reported compliance during oral appliance therapy for sleep-disordered breathing

BACKGROUND Assessment of the overall therapeutic effectiveness of oral appliance therapy can only be realized through objectively measured compliance. The aims of this study were to assess objectively measured compliance during oral appliance therapy at 1-year follow-up and to compare these data with self-reported use. METHODS Fifty-one eligible patients were enrolled in this 1-year prospective clinical study (men, 61%; mean age, 49 ± 10 years; apnea-hypopnea index, 18.0 ± 11.9 events/h sleep; BMI, 26.6 ± 4.1 kg/m²). Objective compliance during oral appliance therapy at 1-year follow-up was assessed with a microsensor thermometer. Subjective compliance was assessed by self-report. Patients with a mean objectively measured use of ≥ 4 h/night on 70% of nights monitored were considered regular users. The mean disease alleviation was calculated as a measure of overall therapeutic effectiveness. RESULTS High agreement between objective and subjective compliance data at 1-year follow-up was reported (intraclass correlation coefficient, 0.8; 95% CI, 0.5-0.9), showing a mean subjective overestimation of 30 min (95% CI, -3.1 to 1.9; P = .02). The discontinuation rate at 1-year follow-up was 9.8%. The objective mean use rate was 6.4 ± 1.7 h/night at 1-year follow-up in continuing users, with a regular use rate of 83%. The mean disease alleviation was 54.9%. CONCLUSIONS This study is the first to our knowledge to report the 1-year results of objectively measured compliance during oral appliance therapy. In addition, a high agreement between objective and subjective compliance data were reported, with a mean subjective overestimation of 30 min. TRIAL REGISTRY ClinicalTrials.gov; No.: NCT01284881; URL: www.clinicaltrials.gov.

Current opinions and clinical practice in the titration of oral appliances in the treatment of sleep-disordered breathing

Obstructive sleep apnea is characterized by recurrent obstruction of the upper airway during sleep, resulting in episodic reductions in blood oxygen saturation and arousals from sleep. Mandibular repositioning appliances (MRAs) which are worn intra-orally at night, mechanically advance the mandible to help maintain a patent oropharygeal airway and have been proven to be an effective alternative for continuous positive airway pressure in the treatment of obstructive sleep apnea. Titratable MRAs are designed to gradually protrude the mandible applying an easy-to-use mechanical advancing mechanism, until a protrusive position with positive effect on sleep apnea is reached. Considering the relatively low-tech approach of the basic advancement mechanism, the interest in the mechanistic element of the dental treatment of obstructive sleep apnea has increased. The present paper provides an overview of the different titration protocols described in the recent literature together with a discussion of both the clinical and mechanical aspects of treatment. At present, a consensus exists that an optimal titration protocol is of primary importance to achieve a successful treatment outcome with an MRA. To date however, there is no consensus on how to define the optimal titration protocol.

Prevalence and Clinical Significance of Supine-Dependent Obstructive Sleep Apnea in Patients Using Oral Appliance Therapy

STUDY OBJECTIVE The prevalence of supine-dependent obstructive sleep apnea (sdOSA) in a general population ranges from 20% to 60%, depending on the criteria used. Currently, the prevalence and evolution of sdOSA once oral appliance therapy with a mandibular advancement device (OAm) has started is unknown. In addition, literature on the correlation between sdOSA and treatment success with OAm is not unequivocal. The first purpose of this study was to assess the prevalence of sdOSA before and under OAm therapy. Second, the conversion rate from non-sdOSA to sdOSA during OAm therapy was evaluated. The third and final goal was to analyze the correlation between sdOSA and treatment success with OAm therapy in the patient population. METHODS Two hundred thirty-seven consecutive patients (age 48 ± 9 years; male/female ratio 173/64; AHI 20.1 ± 14.7 events/h; BMI 27.2 ± 4.3 kg/m(2)) starting OAm therapy were included. RESULTS The prevalence of sdOSA before the start of OAm therapy, ranged from 27.0% to 67.5%. The prevalence of residual sdOSA under OAm therapy in this study ranged from 17.5% to 33.9%. Second, the conversion rate from non-sdOSA to sdOSA ranged from 23.0% to 37.5%. Third, the presence of sdOSA at baseline was not a significant factor for treatment success with OAm therapy. CONCLUSIONS The results of this study indicate that the prevalence of sdOSA before and under OAm therapy is relatively high. One-third of patients shift from non-sdOSA to sdOSA. Finally, treatment success for OAm therapy was not significantly correlated with the presence of sdOSA at baseline.

Development of a Clinical Pathway and Technical Aspects of Upper Airway Stimulation Therapy for Obstructive Sleep Apnea

Obstructive sleep apnea (OSA) is a common disease with high morbidity and related mortality. Narrowing and collapse of the pharyngeal airway during sleep characterize the disease, resulting in a decrease (hypopnea) or a complete cessation (apnea) of oronasal airflow. Upper airway stimulation (UAS), using electrical neurostimulation of the hypoglossal nerve (n. XII) synchronized with ventilation, is a novel, evolving treatment option. UAS was found to be an effective treatment in CPAP-intolerant patients. The treatment success is partly due to the strict selection of the patients, based on previous findings. Furthermore, post-operative follow-up is needed in order to maintain or improve treatment outcome. Therefore, a clinical pathway, which provides structure and standardization, is crucial. In this paper, the aim is to discuss the technical aspects of UAS therapy and to describe a clinical pathway to organize the care process of UAS for OSA in a structured and standardized way.

Prevalence of residual excessive sleepiness during effective oral appliance therapy for sleep-disordered breathing

BACKGROUND Oral appliance therapy with a mandibular advancement device (OAm) can yield to complete therapeutic response (apnea-hypopnea index [AHI]<5 events/h), though some patients show little or no improvement in daytime sleepiness. The prevalence of residual excessive sleepiness (RES) despite effective treatment with OAm therapy is unknown. We aimed to determine the prevalence of RES in patients treated with a titratable custom-made duobloc OAm. METHODS A prevalence study was performed, collecting data from 185 patients with an established diagnosis of sleep-disordered breathing (SDB) under OAm therapy with a titratable custom-made duobloc device (baseline data were male:female ratio, 129:56; age, 48±9 years; body mass index [BMI], 27±4 kg/m2; Epworth Sleepiness Scale [ESS] score, 10±5; and AHI, 19±12 events/h). A full-night polysomnography was performed at baseline and after 3 months of OAm therapy. Daytime sleepiness was assessed using the ESS with RES defined as an ESS score of 11 or higher out of 24, despite complete therapeutic response. RESULTS Out of 185 patients, 84 patients (45%) showed a complete therapeutic response with an AHI of <5 events per hour after 3 months of OAm therapy. Despite this normalization of AHI, 27 out of these 84 patients (32%) showed RES and had a significantly higher baseline ESS (15±4 vs. 9±4; P<.001) and were younger (43±9 vs. 47±9; P=.028) compared to patients without RES. CONCLUSION RES under OAm therapy showed a prevalence of up to 32% in SDB patients effectively treated with respect to AHI. Patients with RES were younger and had higher baseline daytime sleepiness.

Comparison of upper airway collapse patterns and its clinical significance: drug-induced sleep endoscopy in patients without obstructive sleep apnea, positional and non-positional obstructive sleep apnea

PurposeTo compare patient characteristics, upper airway (UA) collapse patterns and treatment outcome in obstructive sleep apnea (OSA) patients, including non-positional OSA patients (NPP) and positional OSA patients (PP), and non-OSA.MethodsCohort study of patients screened for OSA in 2012. Polysomnography was performed and UA was evaluated using the VOTE classification during drug-induced sleep endoscopy (DISE). Treatment outcome of MAD and UA surgery was evaluated.ResultsEight hundred sixty patients were included. Higher BMI, larger neck circumference, and greater age were independent significant predictors for OSA. DISE was performed in 543 patients: 119 non-OSA and 424 OSA patients of whom 257 PP and 167 NPP patients. PP were younger, had smaller neck circumference, lower BMI and apnea-hypopnea index (AHI) than NPP. Collapse at velum (p < 0.001) and oropharynx (p < 0.001) significantly increased the odds for having OSA. Tongue base and epiglottis collapse were, on group level, not determinative for OSA or non-OSA. Complete concentric collapse (CCC) was observed less frequently in PP (31.5%) as compared to NPP (46.1%). After UA surgery, OSA often was cured or improved to less severe positional OSA. Lower efficacy of UA surgery was observed in PP as compared to NPP. No differences were observed in MAD treatment outcome.ConclusionsCurrent study provides insight in patients screened for OSA: collapse at velum and oropharynx significantly determined presence of OSA and CCC occurred less frequently in PP compared to NPP. In addition, residual positional dependency is common after UA surgery. More trials are needed to gain insight in pathophysiology and treatment outcome.

Remotely Controlled Mandibular Positioning During Drug-Induced Sleep Endoscopy Toward Mandibular Advancement Device Therapy: Feasibility and Protocol

STUDY OBJECTIVES The potential of a remotely controlled mandibular positioner (RCMP) during sleep studies in individual patients suffering from obstructive sleep apnea (OSA) for the determination of the effective target protrusive position (ETPP) of the mandible has been demonstrated. The research goal of this study was to assess the feasibility of the application of RCMP during drug-induced sleep endoscopy (DISE) for the determination of ETPP. METHODS Ten patients in whom OSA was diagnosed (50% male; age 54 ± 9.5 years; body mass index 26.9 ± 2.1 kg/m2; apnea-hypopnea index 28.4 ± 13.2 events/h) were enrolled prospectively. Dental RCMP trays were fitted during wakefulness. Maximal protrusion and edge-to-edge positions were measured. Upper airway collapsibility was scored during DISE, including full-range mandibular RCMP titration within 45 minutes. ETPP was defined as the mandibular threshold protrusion yielding a stable upper airway in the absence of snoring, oxygen desaturation and apneas. RESULTS RCMP trays were retentive and no adverse reactions occurred. RCMP was fitted intraorally prior to sedation with maxillary and mandibular trays in edge-to-edge position. Upon sedation, progressive protrusion was performed followed by reversed titration until ETPP was noted. In one patient ETPP was not within the mandibular range of motion. In one patient RCMP needed to be removed because of clenching. CONCLUSIONS The results of this study illustrate that it is feasible to use RCMP during DISE and to determine ETPP within 45 minutes. Comparative research with polysomnography would be useful to further validate the therapy outcome upon use of RCMP during DISE.