Why MAD-FITTM?
Elevating the Practice of Dental Sleep Medicine
Welcome to APP-NEATM, the definitive educational and clinical resource center dedicated to the treatment of sleep disordered breathing, including obstructive sleep apnea (OSA) and snoring. Our flagship product, MAD-FITTM, streamlines the practice of oral appliance therapy for disordered sleep breathing, It makes patient's journeys to consistent sleep quality and full night sleeps smoother and faster.From patient education about OSA to connecting them with the appropriate network of professionals, to development and management of professional education and networks, to superior clinical and administrative systems and support for the professionals, we’ve got it covered.The long-term goal of APP-NEATM, LLC is to make the practice of dental sleep medicine predicable, efficient and effective for all dentists no matter where they practice across the globe. Dental sleep medicine focuses on the treatment of sleep-disordered breathing using oral “appliance” (mouthpiece) therapy. Patients and dentists alike have a common motivation to have their oral appliances fit comfortably and perfectly from the start to get patients right away to the point where they can rest comfortably and wake up refreshed on a consistent basis.
Treating Sleep Apnea:
It’s Not Complicated
The most common treatment for sleep apnea is Continuous Positive Airway Pressure (CPAP) therapy. The CPAP machine keeps the airway open by forcing air through flexible tubing to a face mask the patient wears to sleep. Although this therapeutic option is effective for those who use it consistently and correctly every night, many do not tolerate the CPAP. Even more use their CPAP only part of the time.Oral appliances (similar to mouth guards) are an alternative treatment option for those who struggle with OSA or snoring. Many patients prefer oral appliances because they are comfortable, quiet, portable and easy to wear. The American Academy of Sleep Medicine (AASM) currently recommends the use of oral appliances, known as, “ Mandibular Advancement Devices” when applied to the treatment of sleep-disordered breathing, as the preferred treatment for those diagnosed with “mild” to “moderate” OSA. Even in the case of those with “severe” sleep apnea, AASM recommends the use of an oral appliance if the patient cannot tolerate (meaning that they are “non-compliant” with) a CPAP.Unfortunately, oral appliances are often very challenging and inconvenient to fit. A patient is typically required to visit their dentist for “trial-and-error” fitting multiple times before their oral appliance can fit comfortably.
How it works
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Multidimensional analysis of thousands of data-points from comprehensive clinical, radiologic, and polysomnographic evaluation of the patients resulted in the engineering of the MAD-FITTM predictive algorithm.
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It allows the dentist to determine the optimal titration point, bypassing the highly subjective and unscientific trial and error titration method.
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This prevents the tongue from falling back and blocking the throat and distracts it away from the roof of the mouth to achieve maximum effective passive breathing, thereby reducing the sleep apnea index.
Clinically Proven Results
Three hundred and ninety sleep apnea patients underwent treatment with a serially titrated MAD. Serial titration continued until there was no change in subjective findings. This was followed by an overnight polysomnograph study at three months post final titration, after which all patients were also given a one-piece non-adjustable MAD set in the final titration position. Each titration measurement, ESS assessment, and compliance of all patients was recorded at each titration visit and at their annual follow up visits. Characteristics of the 330 patients who completed overnight polysomnography did not significantly differ from those who did not.
In the set of 390 patients with treatment outcome data, 205 were males and 185 females. In the male subset, 166 completed the program by taking a post titration overnight sleep study; 39 did not follow up with an overnight sleep study. Responders and non-responders did not differ significantly in terms of age, or neck circumference. There were no differences between responders and non-responders in baseline upper airway structure; however, differences were observed in changes in velopharyngeal measurements. Responders showed a greater increase in A-P diameter, minimum CSA, mean CSA and volume. Of the female patients, 145 followed through to the post titration overnight sleep study and 40 did not. There were no significant differences in age, BMI, and neck circumference. Baseline and changes in upper airway structure did not differ between responders and non-responders. There was no linear relationship between changes in AHI and airway volume. Cephalometric measurements and soft tissue centroid movements did not differ between treatment responders and non-responders. However, it did appear that differences in the degree of mouth opening, as assessed by the cephalo-metric measure ANS-Gn, induced by the appliance had an impact on treatment outcome. These findings conclude that the volumetric changes in the airway are multifactorial, and unlike previously thought, the degree of opening of the mouth has a direct result on the changes experienced in the oral airway and lateral positioning with the comfort and compliance of the MAD.
In a cross-tabulation of these 390 patients, there was no correlation between total airway and velopharyngeal volume changes between responders (those who completed the entire program including post-titration sleep study) and non-responders. However, changes in oropharyngeal volume appear to show some consistency between the two. The optimally-titrated MAD altered upper airway geometry, associated with movement of the parapharyngeal fat pads away from the airway and increased velopharyngeal lateral diameter to a greater extent and also increased antero-posterior diameter with anterior displacement of the tongue and soft palate.
The MAD resulted in anterior displacement of the tongue base muscles, (AHI reduction ≥ 50%) and increased velopharyngeal volume relative to the baseline. The study concluded that a properly titrated MAD had a higher degree of compliance than CPAP therapy and was as effective in managing mild to moderate sleep apnea and in candidates with non-CPAP-compliant severe sleep apnea. The MAD was instrumental in a significant volumetric increase in the airway and decreasing the sleep apnea indices. Using the data generated by this large clinical study and his hypotheses on what determines effective final (optimal) titration of a MAD, Dr. Singh developed a proprietary optimal titration (best fit) algorithm and fit it statistically. A follow-up multicenter effectiveness study to test the stability and accuracy of the MAD-FITTM algorithm included 125 patients with the same inclusion criteria as the initial study.
This follow-up study concluded the MAD-FITTM algorithm calculated the end titration jaw position faster and more precisely than serial titration (trial-and-error) allowing the patients to experience better sleep from the first night of treatment with an oral appliance. Of the 125 patients treated with the MAD-FITTM algorithm, 115 patients were compliant with the MAD for four nights or more per week, 103 patients reported successful treatment from the first night of wearing a MAD, and only 21 patients required further titration ranging from -1.8 mm to +2.4 mm with a subset mean of +/-0.8mm.