Predicting oral appliance treatment outcomes with a new medical diagnostic device.
Continuous Positive Airway Pressure (CPAP) is a highly efficacious treatment for obstructive sleep apnea (OSA); however, CPAP effectiveness is limited by non-compliance rates of between 60% and 80%.1-3 Oral appliances (mandibular advancement splints) provide a therapeutic alternative to CPAP, but the inability to predict prospectively which patients will benefit from oral appliance treatment affects success rates.
SomnoMed MATRx (Figure 1) is a revolutionary medical diagnostic device that provides, for the first time, a prospective means for predicting SomnoDent treatment outcomes during a polysomnographic study (PSG). Validated in two previous studies,4,5 SomnoMed MATRx patented technology was developed by Zephyr Sleep Technologies’ chief medical officer, Dr. John Remmers.
To use this medical diagnostic device, dental expertise is required to first assess the patient’s candidacy for a SomnoDent. The dentist then fits the patient with a temporary oral appliance, proprietary to SomnoMed MATRx. The temporary appliance consists of upper and lower titration trays that are prepared in the following way:
- The trays are filled with impression material and inserted into the mouth parallel to the tooth axes and depressed over the teeth.
- Excess impression material is trimmed off the trays to ensure optimal comfort and fit.
- Using the proprietary scale on the titration trays, three measurements are taken to characterize the patient’s mandibular range of motion: habitual bite position; maximum voluntary protrusion of the mandible; and full retrusion of the mandible.
Once the temporary oral appliance is ready and the patient’s mandibular range of motion is characterized, the patient proceeds to their local sleep center to undertake an attended polysomnographic (PSG) sleep study, where a sleep technologist enters the three measurements taken by the dentist into the system software to ensure patient safety as the mandible is moved during the sleep study. The temporary oral appliance trays are then attached to an actuator that is remotely controlled by the sleep technologist while the patient sleeps. This enables the sleep center to conduct an oral titration sleep study in a process analogous to an industry standard CPAP titration study. During this study, the mandible is progressively advanced as directed by the sleep technician during sleep until respiratory events and oxygen desaturation are eliminated.
Using SomnoMed MATRx in a PSG environment enables sleep physicians to ascertain the effectiveness of oral appliance therapy for their patients and helps them to determine the optimum settings for the oral appliance. With this information in hand, both the sleep physician and dentist can have confidence in the therapeutic outcome of oral appliance therapy for OSA.
SomnoMed’s CEO, Ralf Barschow, adds that, “OSA and/or non-compliant CPAP patients will now have an alternative that is non-invasive and comfortable and will be shown during a sleep study to be effective. This gives the sleep physician comfort to prescribe the next generation OSA treatment solution, the SomnoDent G2.”
SomnoDent G2 is a revolutionary modular advancement system providing unparalleled control to the dentist throughout the entire therapy with simple “click-on, click-off” advancement. SomnoMed’s new medical oral appliance’s proprietary design is metal-free with a slim profile placing patients in the most comfortable and desirable location for apnea treatment. This device has greater anterior-posterior range as well as new lateral and vertical movement control options.
SomnoDent G2s will also be accompanied by a premium travel case with bedside storage and maintenance kit for the patient. An adjustment kit will also be provided which contains the modular components.
The developers of the SomnoDent® MAS, a clinically validated mandibular advancement splint approved in 2004 after 7 years of clinical research, SomnoMed fosters an evidence-based approach to OSA treatment.
1. Weaver TE, Sawyer AM. Adherence to continuous positive airway pressure treatment for obstructive sleep apnoea: implications for future interventions. Indian J Med Res. 2010;
2. Pépin JL, Krieger J, Rodenstein D, et al. Effective compliance during the first 3 months of continuous positive airway pressure: a European prospective study of 121 patients. Am J Respir Crit Care Med. 1999;160(4):1124-1129.
3. Kribbs NB, Pack AI, Kline LR, et al. Effects of one night without nasal CPAP treatment on sleep and sleepiness in patients with obstructive sleep apnea. Am Rev Respir Dis. 1993;147
4. Tsai WH, Vazquez J, Oshima T, et al. Remotely controlled mandibular positioner predicts efficacy of oral appliances in sleep apnea. Am J Respir Crit Care Med. 2004;170(4):366-370.
5. Dort LC, Hadjuk E, Remmers JE. Mandibular advancement and obstructive sleep apnoea: a method for determining effective mandibular protrusion. Eur Respir J. 2006;27(5):
This information concerns a use that has not been approved or cleared by the Food and Drug Administration.
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