FDA Oral Appliance Therapy (OAT)

Not everyone who snores has Obstructive Sleep Apnea (OSA), but it is a key symptom. The clinical difference with Obstructive Sleep Apnea (OSA), is that the snoring is accompanied by short pauses and people stop breathing because the airway collapses or is blocked. 

Oral Appliance Therapy (OAT) mainly treats sleep-related breathing disorders, such as obstructive sleep apnea (OSA). The therapy aims to enhance breathing during sleep, but it can also benefit patients with hypertension, obesity, cardiovascular, and poor glycemic control indirectly. Collaborating with primary care providers and sleep medicine specialists can help achieve these benefits. Some of the expected benefits include:

1. Improved Sleep Quality: OAT can help alleviate sleep apnea symptoms, such as snoring and breathing interruptions, leading to better sleep quality. Improved sleep may positively impact overall cardiovascular health.

2. Reduced Cardiovascular Strain: Sleep apnea has been linked to an increased risk of cardiovascular problems, including hypertension, arrhythmias, and heart failure. Effectively managing sleep apnea with OAT may reduce the strain on the cardiovascular system.

3. Blood Pressure Management: Treating sleep apnea can improve blood pressure control. Many individuals with sleep apnea also have hypertension, and addressing sleep-related breathing issues may complement traditional hypertension management.

4. Enhanced Compliance: Some patients may find OAT more comfortable and easier to comply with than continuous positive airway pressure (CPAP) therapy. Better compliance with treatment recommendations can lead to more consistent improvements in cardiovascular health.

5. Collaborative Care: Collaboration between cardiologists and sleep medicine specialists ensures a comprehensive approach to addressing cardiovascular and sleep-related problems. This interdisciplinary approach may lead to more effective and personalized patient care.

Medical providers, must consider the patient's overall health condition, specific cardiovascular issues, and the severity of sleep-related problems to determine the best course of treatment. Communication and collaboration among specialists are critical for providing the best patient care possible.

Benefits

• FDA cleared to treat snoring, as well as mild to moderate obstructive sleep apnea (OSA).

• Fit in 15 minutes, allowing same-day treatment.

• Refit as many times as needed.

• Most affordable sleep therapy.

OSA is as High as 80% in Patients with Hypertension, Heart Failure, Coronary Artery Disease, Pulmonary Hypertension, Atrial Fibrillation, and Stroke

https://www.ahajournals.org/doi/10.1161/CIR.0000000000000988

OAT vs CPAP

Oral Appliance Therapy (OAT) and Continuous Positive Airway Pressure (CPAP) therapy are both effective treatments for sleep-related breathing disorders, such as obstructive sleep apnea (OSA). The choice between OAT and CPAP depends on various factors, each with its own benefits. Here are some advantages of Oral Appliance Therapy over CPAP:

1. Comfort and Convenience:

   - OAT: Oral appliances are smaller, more portable, and generally more comfortable than CPAP machines. They do not involve masks, hoses, or the need for electricity, making them convenient for travel.

   - CPAP: CPAP therapy involves wearing a mask over the nose or nose and mouth, connected to a machine that delivers a continuous stream of air. Some individuals find the mask uncomfortable or experience difficulty adjusting to the airflow pressure.

2. Ease of Use:

   - OAT: Oral appliances are simple to use and do not require extensive setup or maintenance. Patients can easily insert or remove the appliance without relying on complex equipment.

   - CPAP: CPAP machines involve more components, including masks, hoses, and filters. Some individuals find the setup and maintenance of CPAP machines to be more involved.

3. Quiet Operation:

   - OAT: Oral appliances do not produce noise, providing a quieter sleep environment for the user and their bed partner.

   - CPAP: CPAP machines can be noisy despite their modern designs.

4. High Compliance Rates:

   - OAT: Some people who struggle with CPAP compliance due to discomfort or claustrophobia may find oral appliances more tolerable, leading to higher adherence rates.

   - CPAP: Compliance with CPAP therapy can be challenging for individuals who find the mask uncomfortable or experience difficulty adjusting to the airflow pressure.

5. Treatment for Mild to Moderate OSA:

   - OAT: Oral appliances effectively treat mild to moderate obstructive sleep apnea.

   - CPAP:* CPAP is often recommended for moderate to severe cases of sleep apnea. While it is highly effective, some individuals may prefer alternative treatments.

People with sleep-related breathing disorders should talk with their healthcare provider or sleep specialist about their symptoms, preferences, and lifestyle.

Journal of Dental Sleep Medicine Vol 7, Nov 3, 2020

Snoring and Sleep Apnea

The most common type is Obstructive Sleep Apnea (OSA) which occurs when the muscles in the back of the throat fail to keep the airway open, despite efforts to breathe. The breathing pauses repeatedly occur during sleep and last at least ten (10) seconds at a time for a minute or longer. In recent years, there is mounting data where obesity and obstructive sleep apnea sit at the epicenter and its control can lead to improvement and prevention of diabetes and cardiovascular complications. Symptoms related to sleep or screening for sleep apnea have been overlooked by cardiac, diabetic, pulmonary, and general medicine clinics despite recommendations for screening by several societies.

OSA was Found in Over 70% of Type 2 Diabetics in a Meta-Analysis, Therefore Clinicians Should Consider Treatments for Patients.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3449487

Data has been in the scientific literature for several years, indicating the associations of OSA with almost any disease like glaucoma, end-stage renal disease, chronic obstructive pulmonary disease, polycystic ovarian syndrome, metabolic syndrome, cardiovascular disease, stroke, depression, obesity, and DM. OSA has also been identified in non-obese patients and children with enlarged tonsils and adenoids. Moreover, the treatment has led to improvements in the underlying condition [36-38]. Early diagnosis and treatment of OSA will help in preventing the increased morbidity and mortality associated with those conditions. Studies have shown that improvement in ejection fraction, carotid intimal thickening and benefits in coronary artery disease, maintenance of sinus rhythm from A-Fib after cardioversion, and improvement in insulin resistance while untreated OSA is associated with an increased risk of death. 

Early Diagnosis and Treatment of OSA can Significantly Reduce Morbidity and Mortality Risks

OSA, COVID, and CPAP Recall

Breathing is mandatory to sustain life and we often take it for granted until we start having trouble breathing. The novel coronavirus SARS-CoV-2 is a highly transmissible virus that causes respiratory illness in humans that can lead to death. It emerged in late 2019 and has caused a pandemic of acute respiratory disease, named ‘coronavirus disease 2019’ (COVID-19). Obstructive Sleep Apnea (OSA) involves compromised breathing during sleep and is most often managed with Positive Airway Pressure (PAP) and uses pressurized air to maintain airway patency during sleep. PAP has been considered the “First Line” therapy for OSA since it was first introduced in the early 1980s. Dentistry has used an alternative to PAP for the management of OSA, with an Oral Appliance (OA), which maintains airway patency during sleep by holding the jaw in a forward position. Studies demonstrate that only 30-40% of patients wear their PAP all night, versus approximately 90% for Oral Appliances (OA). Measurements of therapeutic benefit are similar for both devices, believed to be due to this much higher compliance rate. 

Patients on CPAP Devices Should be Prescribed an Oral Appliance (OA) to Patients Who Snore or Have Been Diagnosed with OSA or COVID-19.

PAP has been implicated with spreading COVID-19 within the Washington state nursing home in February 2020 which became ground zero in North America during this Pandemic. The First Responders that responded to the Life Care nursing facility in Kirkland Seattle in late February used nebulizers and PAP machines to treat patients. “It’s best practice for us for people with respiratory illnesses,” said Jim Whitney, medical services administrator for the Redmond Fire Department. “We had no idea that we potentially had COVID patients there… We essentially aerosolized it,” said one responder after the fact, “We made it worse”. It was only later that King County public health officials advised Redmond Fire and other first responders in the region not to use PAP for patients suspected of having COVID-19 illness. Whitney said responders were using machines with specialized filters, which can reduce the amount of virus released. But King County public health authorities recommend that first responders avoid using PAP altogether. Redmond Fire has now discontinued the use of PAP for COVID-19 patients. 

An Oral Appliance (OA) can Easily be Disinfected to Kill COVID-19 Viruses by Patients and Does Not Share Any of the Aerosol Liabilities Associated with PAP Devices

The American Academy of Sleep Medicine currently recommends that if a PAP user becomes positive for COVID-19, they should speak to their physician about assessing the risks and benefits of continuing to use the PAP device at home. Persons at risk for infection from continued PAP usage include all cohabitants of the same household. In these cases, an Oral Appliance (OA) could be considered an effective alternative to PAP. For these reasons, on November 3, 2020, an official position statement by the American Academy of Dental Sleep Medicine (AADSM) stated the following: Oral Appliance Therapy Should be Prescribed as a First-Line Therapy for OSA during the COVID-19 Pandemic (the official AADSM statement is listed below).

More Contagious Variants of COVID-19 will Continue to Emerge, and Simpler Alternatives Like Oral Appliances (OA) Should be First-Line Therapy 

On June 2021, Phillips's Respironics recalled millions of CPAPS, Bilevel PAPs, and Ventilators which sent shock waves throughout sleep medicine and has resulted in sleep lab administrators and sleep clinicians searching for alternative sleep apnea therapies for their patients. Even the very best fitting PAP devices leak, this is simply a limitation of the technology and acknowledged as acceptable by ResMed, the inventor of PAP. Now that we know about the liability associated with PAP, we should never forget it - prescribe only oral appliances.

Credit to John Viviano can be reached at John@DrViviano.com, Office: 905 212 7732, Cell: 416 500 2901 

If you're interested in partnering with us, click here to schedule a call and review product offerings and billing insights.