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MAD-FIT™ Makes Professional Treatment of Most Sleep Apnea Patients Scientific, Quick and Easy

Elevating the Practice of Dental Sleep Medicine

Welcome to APP-NEA™ , 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-FIT™ , streamlines the practice of oral appliance therapy for disordered sleep breathing, making patients’ journeys to consistently 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 longterm goal of APP-NEA™ , LLC is to make the practice of dental sleep medicine predicable, ef ficient and effective for all dentists no matter where they practice across the globe. Dental sleep medicine focuses on the treatment of sleepdisordered 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 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 ef fective for those who use it consistently and correctly every night, many do not tolerate the CP AP. This presents a challenge for many people to adhere to its prescribed usage.

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 CP AP.

Unfortunately, oral appliances are often very challenging and inconvenient to fit. A patient is typically required to visit their dentist for “trialanderror” fitting multiple times before their oral appliance can fit comfortably .

MAD-FIT™ Makes Fitting Oral Appliances Faster and Easier

Dr. Pankaj Singh, the founder of APP-NEA™ LLC, has been devoted to finding a more scientific approach to fitting therapy in oral appliances for much of his career. Hundreds of patients, a major clinical study and over a decade of research later , Dr. Singh has developed a predictive algorithm that determines the ideal and most comfortable jaw position for an oral appliance for ef fective airway management of OSA in a single patient visit.

We named the algorithm "MAD-FIT™ " for the perfect fit and position it gives a Mandibular Advancement Device (MAD) from the very first visit. The algorithm allows dentists to bypass the current unscientific, subjective, and timeconsuming trial and error method of serial titration of an oral appliance. A patient’ s breathing is improved from the first time they wear a MAD-FIT™ titrated appliance. Our method uses up to date analytics and clinically relevant data to engineer the threedimensional positioning of the jaw by an oral appliance.

MAD-FIT™ : How it Works in a Nutshell

Multidimensional analysis of hundreds of thousands datapoints from comprehensive clinical, radiologic and polysomnographic evaluation of the patients resulted in the engineering of the MAD-FIT™ predictive algorithm. This allows the dentist to determine the optimal titration point, bypassing the highly subjective and unscientific trial and error titration method. 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

390 OSA 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 3 months post final titration, after which all patients were also given a one piece nonadjustable 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 dif fer 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 not follow up with an overnight sleep study . Responders and nonresponders did not differ significantly in terms of age, or neck circumference. There were no differences between responders and nonresponders in baseline upper airway structure , however dif ferences were observed in changes in velopharyngeal measurements. Responders showed a greater increase in AP 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 dif ferences in age, BMI and neck circumference. Baseline and changes in upper airway structure did not dif fer between responders and nonresponders. There was no linear relationship between changes in AHI and airway volume. Cephalometric measurements and soft tissue centroid movements did not dif fer between treatment responders and nonresponders. However, it did appear that dif ferences in the degree of mouth opening, as assessed by the cephalometric measure ANSGn, 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 crosstabulation of these 390 patients, there was no correlation between total airway and velopharyngeal volume changes between responders (those who completed the entire program including posttitration sleep study) and nonresponders. However, changes in oropharyngeal volume appear to show some consistency between the two.

The optimallytitrated 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 anteroposterior 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 OSA and in candidates with nonCPAPcompliant severe OSA. 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 followup multicenter effectiveness study to test the stability and accuracy of the MAD-FIT™ algorithm included 125 patients with the same inclusion criteria as the initial study. This followup study concluded the MAD-FIT™ 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-FIT™ algorithm, 115 patients were compliant with the MAD for 4 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.

The APP-NEA™ Approach to a Better Night’s Sleep, Every Night

At APP-NEA™ we believe the key to the successful management of patients with obstructive sleep apnea is a seamless partnership between their dentist and physician. In order to provide patients with the best possible care and control over their condition, our approach to successful OSA treatment is multifaceted. This includes scientific and clinically proven educational resources, clinical and administrative systems, and ongoing support to our physician & dental partners, among other services and resources.

Often, the clinical aspect of sleep apnea and snoring treatment is the least difficult to implement. Because these services crossover into the medical realm, it requires a shift in the way dentists think as care providers. Without proper training in sleep apnea intervention, many dental practices face challenges when attempting to integrate nonclinical aspects to the full picture of OSA treatment. Considerations such as compliance, billing medical insurance and ef fectively communicating with their medical counterparts are examples of such factors that can be overlooked. At APP-NEA™ , we work with dental teams to help them provide effective management of these issues as they work towards a seamless integration of professional services on behalf of the patient.

1) Singh PP. Large Scale, Longitudinal Ef ficacy Study of Management of Obstructive Sleep Apnea (OSA) with a Mandibular Advancement Oral Appliance (MAD). Sleep. Manuscript Number: SP0 0397 16
2) Pankaj P. Singh, DDS, DICOI, DSBOI/ID, FAAID, “Followup Clinical Study Testing Application and Effectiveness of the MADFIT Algorithm“, Working paper, to be submitted to Sleep
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