The scientifically validated Apnea Guard® amounts to a great way for sleep clinicians and patients to inexpensively determine if oral appliance therapy is the right decision.
Oral appliances continue to gain wide acceptance as viable alternatives to CPAP, but even these less intrusive therapies are no slam dunk. Prior to investing in a long-term custom appliance, dentists and sleep docs can now recommend a product called Apnea Guard (made by Advanced Brain Monitoring), which essentially serves as a temporary titration oral appliance.
For a trial appliance, the Apnea Guard is unique in that it provides outcomes equivalent to a custom appliance (see accompanying study). The trial protocol is approved by the FDA for up to 30 nights, a period of time that allows clinicians to first establish and then transfer optimized settings directly to a custom oral appliance. Any trained health care staff can fit the device in less than 15 minutes
Success By Design
Apnea Guard’s design provides 1 mm incremental advancement, a Medicare requirement for a custom appliance. The slight adjustments allow clinicians to determine the optimal jaw position, and apply this information to the custom appliance.
If the relatively inexpensive intermediate step works, sleep medicine practitioners can confidently recommend custom devices, eliminating many elements of uncertainty surrounding oral appliance therapy.
The Apnea Guard allows easy determination of an efficacious jaw position that can be prescribed and articulated to the custom appliance, similar to establishing a pressure setting for CPAP. “We found that custom appliance outcomes were optimized at a setting very close to 70% of maximum voluntary protrusion,” says Philip R. Westbrook, MD, chief medical officer, Advanced Brain Monitoring, and past president, American Academy of Sleep Medicine. “With Apnea Guard, it is easy to determine 70% and then initiate therapy at a slightly less protrusive setting. The patient only needs to make a single adjustment to reach 70% after the initial muscular soreness has subsided. Ideally, the titration study is conducted after the initial adaption and soreness has resolved.”
Westbrook’s ambitious goal is for the Apnea Guard protocol to expand the role of sleep medicine practitioners when it comes to the delivery of oral appliance therapy. To enable this transformation, the simplicity of the Apnea Guard is combined with a Protocol that educates non-dental staff on various aspects of oral appliance therapy necessary to expand their role.
To guide patients though the first week of therapy, the Apnea Guard Protocol includes Daily Comfort Surveys to help patients distinguish between expected side effects vs. complications, which may require a consultation. The trouble-shooting guide assists non-dental staff to respond to patient inquiries triggered by the surveys.
How Does Apnea Guard Benefit Dentists?
The Apnea Guard improves the consistency of oral appliance outcomes by simplifying the number of steps and improving the accuracy of the measurements used to fabricate a custom appliance.
“From our NIH-funded study designed to determine how to improve outcomes with oral appliance therapy, we concluded that process for selecting custom appliance settings had the greatest impact on outcomes,” states Westbrook. “It appeared to be the dentist rather than the oral appliance that was the source of the variability.”
Better outcomes improve confidence among members of the sleep medicine community, leading to increased referrals for oral appliance therapy. Apnea Guard ups the odds by incorporating features shown to be critical to custom appliance success.
“From our study, we reported that the vertical distance between the upper and lower appliance components had an important yet unrecognized impact on outcomes,” explains Todd Morgan, DMD, a Calif-based private practice dentist and co-inventor of Apnea Guard. “Our findings suggest that increased vertical dimension improves outcomes in men and compromises outcomes in women, likely due to differences in airway length. Yet both genders benefit from relative increases in vertical space when the tongues are large or the patient sleeps primarily in the supine position. When the optimal vertical setting is not selected prior to fabrication, rework of the custom appliance is required and the procedure for increasing the vertical dimension chair side requires specialized expertise.”
The Apnea Guard protocol combines the option of three vertical dimensions with a simple system for selecting the appropriate size. The device accurately measures the protrusive range and selects the desirable setting while the bite is being registered at the preferred vertical setting.
The dentist simply removes and submits the retention material with the dental models and submits to their dental lab with the Apnea Guard size and advancement setting. New retention material is fitted so the patient can wear the Apnea Guard while the custom appliance is being fabricated to the optimal settings. The dental lab uses bite registration and Apnea Guard settings to articulate an equivalently positioned custom appliance.
The Apnea Guard reduces the time and effort a patient must commit to the fitting of an oral appliance, while also providing an inexpensive, flexible approach for patients who wishes to trial an oral appliance. “Approximately half of my patients are anxious when they initiate oral appliance therapy,” says Dr. Morgan. “Much of the anxiety stems from the numerous instructions we provide upon delivery of the custom appliance. Patients who are suffering from OSA-related cognitive and memory impairment are being provided verbal instructions as on how to titrate and care for the appliance, and recognize progressive changes in side-effects that could affect their condition. They are simply overwhelmed with information,”
The Apnea Guard Protocol recommends insertion at 1 mm less than 70%, and the patient only needs to make one adjustment prior to reaching the trial endpoint. When the custom appliance is delivered at the optimal setting, the typical patient will require only two visits to the dentist, and the entire process will be completed in 3 to 4 weeks instead of 6 to 12 weeks.
Patients who wish the convenience of an oral appliance when traveling, but may not be ideal candidates for oral appliance therapy (severe OSA), can now undergo a low-risk Apnea Guard trial in collaboration with sleep medicine professionals. Likewise, patients can be afforded an inexpensive trial of oral appliance therapy prior to making the significant financial investment associated with custom fitted devices.
The Apnea Guard also provides patients with a temporary therapeutic solution when CPAP therapy must be interrupted due to a nasal or bariatric surgical procedure. Finally, the Apnea Guard can help manage the risk of hypoxemic related post-surgical complications for at-risk patients who are discharged from the hospital while on narcotic pain medication.
Philip R. Westbrook M.D. became the Chief Medical Officer of Advanced Brain Monitoring after establishing the sleep disorders centers a Cedars-Sinai and Mayo Clinic. He has served as President of the American Academy of Sleep Medicine and received its Distinguished Service Award. He helped found the National Sleep Foundation and was honored with a Lifetime Achievement Award. He collaborated in the development and validation of the Apnea Guard®.
Todd Morgan DMD is a Diplomate of the American Board of Dental Sleep Medicine (AADSM) with over 24 years of dental sleep medicine experience from his private dental practitioner in San Diego, CA. He has co-authored two book chapters and numerous journal articles on oral appliance therapy and served as an AADSM scientific Program Chairman for 2010 and 2011. He served as a sub-investigator in $1.2mm, 2.5 year NIH funded study to understand and improve outcomes with OAT and is a co-inventor of the Apnea Guard®.