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Remotely controlled mandibular positioning of oral appliance therapy during polysomnography and drug-induced sleep endoscopy compared with conventional subjective titration in patients with obstructive sleep apnea: protocol for a randomized crossover trial.

ABSTRACT: BACKGROUND:The amount of mandibular protrusion is a key factor in optimizing the efficacy of mandibular advancement device (MAD) therapy in an individual patient diagnosed with obstructive sleep apnea. This process is called titration and is generally based on resolution of subjective symptoms like snoring and/or daytime sleepiness as a function of protrusion. An objective approach uses a remotely controlled mandibular positioner (RCMP) during a full-night polysomnography (PSG), in analogy with continuous positive airway pressure (CPAP) titration. More recently, the feasibility of RCMP use during drug-induced sleep endoscopy (DISE) titration was reported. METHODS:This randomized crossover trial will compare DISE-assisted titration to PSG-guided titration, as well as with the conventional subjective titration method. The primary outcome is the actual mandibular protrusive position found to be the most optimal for each tested titration procedure. Furthermore, the therapeutic efficacy will be compared among the different titration modalities using level 1 sleep studies. DISCUSSION:Currently, the optimal titration of MAD therapy is most often based on 'trial and error'. The conventional method relies on subjective improvement in symptoms, although this may not provide the most accurate indicator for efficient titration. Therefore, relying on objective criteria in the titration process should be advantageous. In analogy with CPAP, titration of the most optimal mandibular protrusion could be performed using RCMP during an overnight titration PSG. Recently, it was shown that titration under direct visualization of upper airway patency and collapsibility is feasible using the RCMP during DISE. However, no clinical results for such a procedure are as yet available. This study is the first to compare the most optimal mandibular protrusive position according to three titration procedures, as well as to compare the therapeutic efficacy of these titration methods. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03716648 . Registered on 23 October 2018.

SUBMITTER: Dieltjens M

PROVIDER: S-EPMC6820920 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Remotely controlled mandibular positioning of oral appliance therapy during polysomnography and drug-induced sleep endoscopy compared with conventional subjective titration in patients with obstructive sleep apnea: protocol for a randomized crossover trial.

Dieltjens Marijke M Braem Marc J MJ Op de Beeck Sara S Vroegop Anneclaire V M T AVMT Kazemeini Elahe E Van de Perck Eli E Beyers Jolien J Kastoer Chloé C Wouters Kristien K Willemen Marc M Verbraecken Johan A JA Vanderveken Olivier M OM

Trials 20191029 1

<h4>Background</h4>The amount of mandibular protrusion is a key factor in optimizing the efficacy of mandibular advancement device (MAD) therapy in an individual patient diagnosed with obstructive sleep apnea. This process is called titration and is generally based on resolution of subjective symptoms like snoring and/or daytime sleepiness as a function of protrusion. An objective approach uses a remotely controlled mandibular positioner (RCMP) during a full-night polysomnography (PSG), in analo ...[more]

PMID: 31665059

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Project description:Study objectivesOral appliance therapy is not commonly used to treat obstructive sleep apnea due to inconsistent efficacy and lack of established configuration procedures. Both problems may be overcome by information gathered while repositioning the mandible during sleep. The purpose of this investigation was to determine if an unattended sleep study with a mandibular positioner can predict therapeutic success and efficacious mandibular position, assess the contribution of artificial intelligence analytics to such a system, and evaluate symptom resolution using an objective titration approach.MethodsFifty-eight individuals with obstructive sleep apnea underwent an unattended sleep study with an auto-adjusting mandibular positioner followed by fitting of a custom oral appliance. Therapeutic outcome was assessed by the 4% oxygen desaturation index with therapeutic success defined as oxygen desaturation index < 10 h-1. Outcome was prospectively predicted by an artificial intelligence system and a heuristic, rule-based method. An efficacious mandibular position was also prospectively predicted by the test. Data on obstructive sleep apnea symptom resolution were collected 6 months following initiation of oral appliance therapy.ResultsThe artificial intelligence method had significantly higher predictive accuracy (sensitivity: 0.91, specificity: 1.00) than the heuristic method (P = .016). The predicted efficacious mandibular position was associated with therapeutic success in 83% of responders. Appliances titrated based on oxygen desaturation index effectively resolved obstructive sleep apnea symptoms.ConclusionsThe MATRx plus device provides an accurate means for predicting outcome to oral appliance therapy in the home environment and offers a replacement to blind titration of oral appliances.Clinical trial registrationRegistry: ClinicalTrials.gov; Name: Predictive Accuracy of MATRx plus in Identifying Favorable Candidates for Oral Appliance Therapy; Identifier: NCT03217383; URL: https://clinicaltrials.gov/ct2/show/NCT03217383.CitationMosca EV, Bruehlmann S, Zouboules SM, et al. In-home mandibular repositioning during sleep using MATRx plus predicts outcome and efficacious positioning for oral appliance treatment of obstructive sleep apnea. J Clin Sleep Med. 2022;18(3):911-919.

Project description:Study objectivesMandibular protruding oral appliances represent a potentially important therapy for obstructive sleep apnea (OSA). However, their clinical utility is limited by a less-than-ideal efficacy rate and uncertainty regarding an efficacious mandibular position, pointing to the need for a tool to assist in delivery of the therapy. The current study assesses the ability to prospectively identify therapeutic responders and determine an efficacious mandibular position.MethodsIndividuals (n = 202) with OSA participated in a blinded, 2-part investigation. A system for identifying therapeutic responders was developed in part 1 (n = 149); the predictive accuracy of this system was prospectively evaluated on a new population in part 2 (n = 53). Each participant underwent a 2-night, in-home feedback-controlled mandibular positioner (FCMP) test, followed by treatment with a custom oral appliance and an outcome study with the oral appliance in place. A machine learning classification system was trained to predict therapeutic outcome on data obtained from FCMP studies on part 1 participants. The accuracy of this trained system was then evaluated on part 2 participants by examining the agreement between prospectively predicted outcome and observed outcome. A predicted efficacious mandibular position was derived from each FCMP study.ResultsPredictive accuracy was as follows: sensitivity 85%; specificity 93%; positive predictive value 97%; and negative predictive value 72%. Of participants correctly predicted to respond to therapy, the predicted mandibular protrusive position proved efficacious in 86% of cases.ConclusionsAn unattended, in-home FCMP test prospectively identifies individuals with OSA who will respond to oral appliance therapy and provides an efficacious mandibular position.Clinical trial registrationThe trial that this study reports on is registered on www.clinicaltrials.gov, ID NCT03011762, study name: Feasibility and Predictive Accuracy of an In-Home Computer Controlled Mandibular Positioner in Identifying Favourable Candidates for Oral Appliance Therapy.

Project description:Study objectivesThe present study addresses the need for a validated tool that prospectively identifies favorable candidates for oral appliance therapy in treatment of obstructive sleep apnea. The objective of the study was to evaluate the ability of a mandibular titration study, performed with a remotely controlled mandibular positioner (RCMP), to predict treatment outcome with a mandibular repositioning appliance (MRA) and to predict an effective target protrusive position (ETPP).DesignA prospective, blinded, outcome study.SettingStandard clinical care with tests performed in the polysomnographic laboratory.ParticipantsConsecutive patients (n = 67) recruited from a sleep center or a dental practice using broad inclusion criteria (age 21-80 years; AHI > 10/h; BMI < 40 kg/m(2)).InterventionsTherapeutic outcome with a mandibular protruding oral appliance was predicted following a mandibular protrusive titration study in the polysomnographic laboratory using a remotely controlled positioner and prospectively established predictive rules. An ETPP was also prospectively determined for participants predicted to be therapeutically successful with MRA therapy. All participants were blindly treated with a MRA, at either the predicted ETPP or a sham position, and therapeutic outcome was compared against prediction.Measurements and resultsAt the final protrusive position, standard predictive parameters (sensitivity, specificity, positive and negative predictive values) showed statistically significant predictive accuracy (P < 0.05) in the range of 83% to 94%. The predicted ETPP provided an efficacious protrusive position in 87% of participants predicted to be therapeutically successful with MRA therapy (P < 0.05).ConclusionsUsing prospectively established rules for interpreting the polysomnographic data, the mandibular titration study predicted mandibular repositioning appliance therapeutic outcome with significant accuracy, particularly with regard to accurately predicting therapeutic success. As well, among the participants predicted to be therapeutically successful with mandibular repositioning appliance therapy, the effective target protrusive position provided efficacious mandibular protrusion in the majority.

Project description:There is increasing evidence that mandibular advancement devices (MADs) can be an effective treatment for some patients with obstructive sleep apnea, a highly prevalent chronic disease. In this study, the objectives were to objectively assess the effectiveness of MAD therapy using a limited channel recorder, and to develop a model for identifying patients who may be appropriate for MAD therapy as the initial treatment option. Thirty patients were prospectively recruited and studied at two independent dentist offices and the participants' homes. Subjects wore the ARES Unicorder for two nights before insertion of the MAD, and again when the dentist determined that the patient had reached the titration endpoint. Self-reported measures of depression, sleepiness, and quality of life were obtained pre- and posttreatment. The reviewer was blinded to the study status while the physiological signals were being visually inspected. Significant reductions in the apnea/hypopnea index (AHI), hypoxemia measures, and snoring level were observed posttreatment. Twenty-seven of the 30 (90%) patients had a posttreatment AHI (using a 4% desaturation for hypopneas) below a clinical cut-off of 10. All but one patient (97%) exhibited at least a 50% decrease in AHI or had a posttreatment AHI < or = 10. Significant differences in body mass index, weight, and neck circumference in patients with posttreatment AHIs above and below a clinical cut-off of five were identified. The linear regression used to predict the posttreatment AHI using pretreatment data resulted in an R(2) of 0.68. The model correctly predicted two patients who were unable to obtain a posttreatment AHI of 10 or less. This study was designed to demonstrate two models of collaboration between a dental sleep medicine specialist and a sleep medicine physician in the monitoring of a patient treated with a MAD. The outcome data suggest that the limited channel recording system can be used as an alternative to laboratory polysomnography to reduce the cost of MAD treatment, and to improve the quality and consistency of posttreatment patient care.

Dataset Information

Remotely controlled mandibular positioning of oral appliance therapy during polysomnography and drug-induced sleep endoscopy compared with conventional subjective titration in patients with obstructive sleep apnea: protocol for a randomized crossover trial.

Publications

Remotely controlled mandibular positioning of oral appliance therapy during polysomnography and drug-induced sleep endoscopy compared with conventional subjective titration in patients with obstructive sleep apnea: protocol for a randomized crossover trial.

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