In-home mandibular repositioning during sleep using MATRx plus predicts outcome and efficacious positioning for oral appliance treatment of obstructive sleep apnea.

STUDY OBJECTIVES: Oral 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. METHODS: Fifty-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. RESULTS: The 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. CONCLUSIONS: The 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 REGISTRATION: Registry: 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. CITATION: Mosca 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.

Validation of a new unattended sleep apnea monitor using two methods for the identification of hypopneas.

STUDY OBJECTIVES: The objective of the present study was to evaluate the accuracy of a home sleep apnea test (HSAT), MATRx plus (Zephyr Sleep Technologies, Calgary, Alberta, Canada), in identifying apneas and hypopneas and estimating indices of obstructive sleep apnea (OSA). METHODS: Individuals with suspected OSA underwent a one-night study wearing both HSAT and polysomnogram (PSG) sensors. The results provided by the overnight HSAT were compared with those from the simultaneously recorded PSG. The PSG data were scored manually, and the HSAT data were analyzed automatically using both preceding peak (PP) and moving average window (MW) methods for determining the reference oxyhemoglobin saturation (O2 Sat). Accuracy of the HSAT in detecting individual apneic and hypopneic events was evaluated on an epoch-by-epoch basis. The apnea-hypopnea indices from the two recording systems were compared. RESULTS: Agreement analysis for the individual apneic and hypopneic events yielded median values for sensitivity and specificity of 0.89 and 0.98 and positive and negative likelihood ratios of 37.35 and 0.11, respectively. Comparison of OSA indices between the two systems yielded correlation coefficients in the range of 0.95-0.96 and intraclass correlation coefficients ranging from 0.92-0.96. Bland-Altman analyses showed 0-2 cases lying outside the ± 2 standard deviation (SD) band and biases ranging from 2.1 to 5.3 events/h. The biases were larger for MW than PP. CONCLUSIONS: The MATRx plus HSAT identifies apneic and hypopneic events and estimates OSA indices with accuracy suitable for clinical purposes but not in children, patients with underlying lung disease, and habitual mouth-breathers. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: PSG Validation of MATRx plus AHI; Identifier: NCT03627169.

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

STUDY OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: An 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 REGISTRATION: 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.