MicrO2 sleep device used in trial, in part due to digitalization of its fabrication process.
By Peter Blais, RPSGT
An automated mandibular positioning home sleep test (mpHST) enabled immediately
effective treatment for the majority of patients in a recent study; the remaining patients achieved treatment in 1 mm adjustments.
“The take-away from this study is that a mandibular positioning home sleep test can accurately predict the efficacy of oral appliance therapy for individual patients and help speed up the adjustment process,” says Nikola Vranjes, part of the research team that was runner-up for the American Academy of Dental Sleep Medicine’s Clinical Research Award for its poster and abstract “A New Oral Appliance Titration Protocol Using the MicrO2 Sleep Device and Mandibular Positioning Home Sleep Test,” in an interview with Dental Sleep Corner.
Prompting the study, Vranjes explains, was Zephyr Sleep Technologies desire to validate its MATRx technology for patient at-home use, which seeks to be an accessible method to determine if oral appliance therapy is the best treatment option for individual patients. The MATRx-Home is a mpHST that helps patients predict if oral appliance therapy could effectively treat their obstructive sleep apnea (OSA), and if so, what the efficacious target protrusion is. This trial used the MicrO2 appliance.
“I participated in order to understand and assess the potential for a mandibular positioning home sleep test to help me more efficiently customize oral appliances in order to maximize treatment efficacy,” Vranjes says.
The digitization of the MicrO2 fabrication process, Vranjes says, allows for a number of advantages, including a stronger material, ease of obtaining replacements, and the digital shipping of impressions. Additionally, the CAD/CAM fabrication process allows the oral appliance to be customized to the needs of each clinician. To avoid impinging on the retromolar pad area, for example, Vranjes added a 45-degree angle on the posterior aspect of all the upper trays. The device has fixed posts, with incremental adjustments made possible by switching out the arches; Vranjes says this unique feature makes it an ideal appliance to benefit from the target protrusion data provided by Zephyr’s MATRx-Home technology.
It is important to mention that the study was not designed to compare one device to another, Vranjes says, but rather to test the titration technology developed by Zephyr. “The automated titration technology accurately predicted successful outcomes—with an overall 97% accuracy, and a 100% accuracy among patients with severe OSA. Patients readily accepted the predicted effective target protrusion, leading to successful treatment within the first few weeks for the majority of patients. There was a high degree of patient satisfaction, and there were no issues with the patients accepting the incremental adjustments of 1-2 mm.”
Preliminary data included 31 males and 5 females, with a mean age of 48 years and BMI of 33 kg/m 2. Overall, 71% were treated by the MicrO2. By the mpHST test, 58% of patients were predicted to be successfully treated with oral appliance therapy (predicted responders) and all of these were successfully treated by the MicrO2. Of the predicted responders, 81% were treated at target and did not require further protrusion. The remaining four subjects were successfully treated within one to four titration steps using 1 mm advancements.
In explaining how the study results might help dentists dealing with OSA patients, Vranjes says: “The study demonstrates that there is no longer a need to approach oral appliance therapy with a trial-and-error approach—helping the patient save time and money on determining if an oral appliance is an effective treatment. This target titration technology simplifies the whole process for both the patient and the clinician. The conversation can shift from oral appliance therapy being a treatment modality that may or may not work to a conversation about who are the right patients for the therapy, what the target protrusion rate is, what implications the target may have for the patient, etc. The outcome will be increased treatment efficiency and faster time-to-treatment for the patient.”
Vranjes also hopes insurance companies will take note of this technology. “Insurance companies can benefit from mandibular positioning home sleep tests because they help determine early on if oral appliance therapy will be effective, helping insurers improve subscribers’ health and deal with fewer future claims for health conditions related to untreated OSA. By accurately predicting patients’ success rates and decreasing the time-to-treatment, insurance companies, dentists, sleep medicine professionals, and patients will all benefit,” he says.
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