Dataset Information

A Feedback-Controlled Mandibular Positioner Identifies Individuals With Sleep Apnea Who Will Respond to Oral Appliance Therapy.

ABSTRACT: Mandibular 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.Individuals (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.Predictive 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.An unattended, in-home FCMP test prospectively identifies individuals with OSA who will respond to oral appliance therapy and provides an efficacious mandibular position.The 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.

SUBMITTER: Remmers JE

PROVIDER: S-EPMC5482578 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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A Feedback-Controlled Mandibular Positioner Identifies Individuals With Sleep Apnea Who Will Respond to Oral Appliance Therapy.

Remmers John E JE Topor Zbigniew Z Grosse Joshua J Vranjes Nikola N Mosca Erin V EV Brant Rollin R Bruehlmann Sabina S Charkhandeh Shouresh S Zareian Jahromi Seyed Abdolali SA

Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine 20170715 7

<h4>Study objectives</h4>Mandibular 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.<h4>Methods</ ...[more]

PMID: 28502280

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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:BackgroundThe 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.MethodsThis 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.DiscussionCurrently, 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 registrationClinicalTrials.gov, NCT03716648 . Registered on 23 October 2018.

Dataset Information

A Feedback-Controlled Mandibular Positioner Identifies Individuals With Sleep Apnea Who Will Respond to Oral Appliance Therapy.

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A Feedback-Controlled Mandibular Positioner Identifies Individuals With Sleep Apnea Who Will Respond to Oral Appliance Therapy.

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