People use and continue to use the ApneaRx due to it's comfortable design and ease of use.
Over the last 20 years there has been an ever increasing use of oral appliances for the treatment of obstructive sleep apnea and sleep disordered breathing. Oral appliances are offered in two forms: the prefabricated, at a fraction of the cost of a custom fitted dental lab fabricated oral appliance. In Scandinavian countries the preferred interventional therapy for mild to moderate obstructive sleep apnea patient has been primarily an oral appliance, prescribed for 79% of the patients. Compliance with oral appliance is more favorable and only when the patient has severe sleep apnea, CPAP is recommended.
In Canada the dominance of CPAP therapy is quickly surrendering to the oral appliances. Many clinicians were reluctant to prescribe a costly dental lab fabricated oral appliance for fear it might not achieve the same level of desired effectiveness. Thus, the true barrier to oral appliances has been the difficulty to predict a successful outcome. Today, we now have ApneaRx®, The Predictor Device® which for a moderately low cost can accurately predict a patient's success with an oral appliance as validated by Kaiser Permanente hospitals in the US. A pilot study by a team of clinicians from Kaiser Permanente in Fontana, CA evaluated 117 patients and found the ApneaRx 100% predictive of success with a custom oral appliance.
Dr. Robert Mandell said many practitioners find ApneaRx®, a prefabricated oral appliance that can be boiled, cooled and thermally custom fitted in less than 5 minutes, highly convenient. Once fitted, the device can be micro adjusted in 1mm increments, which meets prescribed peer review criteria. I find it particularly interesting that the ApneaRx is not only designed as a temporary device for predicting success with a custom oral appliance, it is robust and durable enough to be worn every night. The importance of this feature is that oral appliance therapy is essentially influenced by the condition of the patient's muscles and ligaments which can relax and adapt over time. It is therefore suggested that the patient wear the appliance for 2 weeks before a titration study is undertaken in order for this adaptation to occur. ApneaRx® is light weight, comfortable and predictive of success if the clinician decides to prescribe an expensive dental lab fabricated customized oral appliance.
Patients can "try before they buy" CPAP therapy and now they can do the same with a prefabricated oral appliance like ApneaRx. If oral appliance therapy is accepted and well tolerated by the patient, a decision can then be made whether a custom oral appliance is needed, or required. Studies indicate that there are a tremendous number of patients for whom the promise of a good night sleep using CPAP did not translate into full compliance and clinical benefit. CPAP acceptance and compliance ranges between 35% - 50%. A significant number of patients (ranging from 30% to 80% in various studies) demonstrate an average CPAP usage of less than 4 hours per night
Best practice standards require that baseline values be established and a treatment protocol with an intervention is followed that takes into account degree and severity of the patient's condition. Single-night titration methods, allowing advancement of the mandible during sleep, have shown promise in predicting likely treatment success and therapeutic level of advancement in a small number of patients using prototype devices such as MatRx®. This method involves use of a remotely controlled intraoral device during an attended sleep study to incrementally advance the mandible until sleep disordered breathing events are eliminated, analogous to a CPAP pressure titration study. If a custom oral appliance is the selected therapy, a follow-up Polysomnogram (PSG) or Home Sleep Test (HST) must be ordered to demonstrate that post treatment values fall into an acceptable range.
In summary, while the Canadian sleep apnea market evolved by choosing CPAP as the first line of interventional therapy, oral appliances are expected to equal, or surpass CPAP therapy in a few short years. Oral appliance is already an established standard of care and first line interventional therapy in many countries. The customized dental lab fabricated oral appliance therapy requires that additional diagnostics and follow-ups be performed to assure physician and patient that the therapy is in fact a viable option and to confirm that the investment in custom oral appliance will meet, or exceed the clinical expectations. The ApneaRx®, 'The Predictor®' is the first and only such device with a peer reviewed independent clinical studies that validates oral appliance therapy as a predictor of success with a custom oral appliance. Furthermore, intervention with the affordable, multi-sized, micro-adjustable, prefabricated ApneaRx® can be offered as a primary therapy for patients with mild to moderate obstructive sleep apnea and alternate therapy for severe obstructive sleep apnea patients who fail CPAP. It is no wonder that more and more Canadian Physicians and Canadian Patients now prefer oral appliances, either prefabricated or custom fitted, over CPAP Therapy.