Once such a device is available to sleep medicine practitioners, dentists will have more confidence treating sleep apnea, according to an AADSM award-winning study.
By Peter Blais, RPSGT
A not-yet-available-for-sale mandibular positioning home sleep test (mpHST) is feasible, safe, and has good predictive accuracy—allowing it to prospectively identify patients who will experience therapeutic success with oral appliance therapy, according to two recent clinical trials. The mpHST also accurately recommends an efficacious protrusion position.
The study, led by John E. Remmers, MD, chief medical officer of Zephyr Sleep Technologies, titled “A Mandibular Positioning Home Sleep Test Prospectively Predicts Outcome of Oral Appliance Therapy for OSA Using Retrospectively Derived Decision Criteria” was recently awarded the American Academy of Dental Sleep Medicine Clinical Research Excellence Award at the 25th anniversary meeting.
“For the past 10-20 years, we have been aware of the relatively poor efficacious rate for oral appliance therapy as a treatment for sleep apnea. The treatment only eliminates the disorder in 50% to 60% of patients,” Remmers says to Dental Sleep Corner in an interview. “The problem is that we have had no way to identify those who will experience therapeutic success. So we treat all referred patients and a substantial segment of the population are left with untreated sleep apnea. This is not a minor problem for a potentially fatal disease.
“Fifteen years ago my colleagues and I invented a device that we hoped would solve this problem. The device, now known as the MATRx titration system and distributed by Zephyr Sleep Technologies, is used by a sleep technician in a sleep lab to eliminate sleep apnea by protruding the mandible in the sleeping patient and, thereby, identifying those patients who will positively respond to oral appliance therapy.
“Our present study evaluates a new technology that is similar to MATRx, but a computer replaces the technician. This means that the test can be carried out at home, reducing costs and providing a more convenient test. Zephyr is developing this new MATRx-home technology because not all patients want to go to a sleep clinic and insurance companies are looking for lower-cost solutions.”
The study explains how Remmers and his fellow researchers conducted two clinical trials using a two- to three-night mpHST in which a computer positions the mandible in response to observed respiratory events. All participants received the mpHST and a custom mandibular protruding oral appliance. Decision criteria applied to the mpHST results yielded a binary prediction of therapeutic outcome.
John E. Remmers, MD
The first trial used decision algorithms derived from a pilot study. The second trial prospectively used new algorithms derived from machine-learning analysis of the results of the first study.
From trial 1 to trial 2, apnea-hypopnea index (AHI) 4% sensitivity increased from 0.78 to 0.88, specificity increased from 0.62 to 0.83, positive predictive value increased from 0.83 to 0.88, negative predictive value increased from 0.55 to 0.83, error rate decreased from 0.27 to 0.14, and success rate decreased from 0.70 to 0.57.
From trial 1 to trial 2, oxygen-desaturation index (ODI) 4% sensitivity increased from 0.78 to 0.80, specificity increased from 0.81 to 1.00, positive predictive value increased from 0.94 to 1.00, negative predictive value increased from 0.50 to 0.67, error rate decreased from 0.21 to 0.14, and success rate decreased from 0.79 to 0.71. Predictive accuracy for predicted efficacious mandibular position decreased from 91% to 81% from trial 1 to trial 2.
The researchers concluded that the mpHST provides a robust prediction of oral appliance therapy success.
How might the results of this study help dentists dealing with oral appliance therapy?
“The results of the study open the possibility that a simple home sleep test will enable sleep medicine professionals to provide oral appliance therapy only to patients that will achieve therapeutic success,” Remmers says. “This will increase the efficiency and effectiveness of dental sleep medicine by providing two important improvements.
“First, the dentist can undertake therapy only for patients who will experience therapeutic success, avoiding non-responding cases that entail numerous clinic visits and yield an unsatisfactory outcome.
“Second, in patients who will be successfully treated, the dentist knows in advance the protrusive position needed to achieve optimal treatment outcomes. Thus, the appliance can be quickly set at or near this position, minimizing the number of clinic visits and tests required for a successful outcome. Additionally, by knowing the effective mandibular position, the dentist cannot over-protrude the mandible, a situation that may occur commonly in the traditional approach to oral appliance therapy.”
The study foreshadows the development of a convenient, reliable, and cost-effective test that will correctly identify patients who will positively respond to oral appliance therapy and accurately provide a target protrusive position for each patient, Remmers says.
This development will have two important implications for the field of dental sleep medicine. First, dentists will have more confidence treating sleep apnea, knowing that patients will positively respond to oral appliance therapy. Second, the use of such a theragnostic test will foster a “precision medicine” approach among sleep specialists dealing with sleep apnea.
“This implies that the goal of therapy is to initiate optimal therapy at the outset of treating the disease. Both therapeutic outcome and cost-effectiveness will improve with this approach,” Remmers concludes.
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