Charlotte Oral Surgery is pleased to announce participation in a clinical trial directed at those who suffer from Obstructive Sleep Apnea (OSA) and are unable to tolerate CPAP treatment, or for those seeking alternative nonsurgical treatment for OSA. As the only East Coast trial location (and one of only three in the United States) those in the eastern US will have access to a new means of determining who best to treat with oral appliance therapy for management of OSA.
OSA, a chronic condition, is probably the most common respiratory disorder afflicting humans, with recent data from the United States and Europe suggesting that between 14 – 49% of middle-aged men and 4 – 50% of women have clinically significant OSA. OSA is more prevalent in men than in women and increases with age and obesity, and presents a significant public health problem: OSA is increasingly recognized as an important cause of medical morbidity and mortality. The condition is characterized by recurrent episodes of partial or complete collapse of the upper airway during sleep. The health consequences of OSA are numerous: if left untreated, OSA leads to excessive daytime sleepiness, cognitive dysfunction, impaired work performance, and decrements in health-related quality of life. Evidence suggests that OSA may contribute to the development of systemic hypertension, cardiovascular disease, stroke, and forms of dementia.
OSA is insidious and those afflicted are often unaware of the associated symptoms. Cardinal manifestations include loud snoring, witnessed breathing pauses during sleep, disrupted sleep quality, and excessive daytime sleepiness. Early recognition and appropriate therapy can ameliorate the neurobehavioral consequences and may also have favorable effects on cardiovascular health.
Standard nonsurgical treatment for OSA (besides weight loss) is continuous positive airway pressure (CPAP), which is highly efficacious, but is associated with low adherence and compliance (particularly in those with milder forms of OSA). The principal alternative to CPAP is oral appliance (OA) therapy, which is used to protrude the mandible during sleep, thereby opening the upper airway. OA therapy, while preferred and well accepted, is not uniformly effective in eliminating OSA. Uncertainty regarding the patient’s response to OA therapy and the effective target mandibular position can lead to a significant time span between diagnosis and initiation of effective treatment. Knowledge of the effective target mandibular position can further reduce the time and costs in delivering appropriate and effective therapy.
Zephyr Sleep Technologies (Calgary, Alberta Canada) (the sponsor of the study) has developed a method for prospectively identifying those who will respond to oral appliance therapy using a remotely controlled mandibular positioning device. While the currently used version of this technology is limited to an in-sleep lab setting, a new portable version of this technology (MATRx™) has been developed by Zephyr that permits use in a portable home testing environment. The device allows healthcare professionals to collect sleep data in the patient’s home rather than in a sleep lab and uses artificial intelligence (random forest modeling) to predict response to therapy and correct mandibular target position.
Providing specialized Oral & Maxillofacial Surgical services, Charlotte Oral Surgery has a history, unique focus and experience in management of those with OSA who have failed CPAP treatment, or are seeking alternative nonsurgical and/or surgical therapies for management of sleep-related breathing disorders, and is one of only a few centers certified nationally by the American Academy of Sleep Medicine for providing oral appliance therapy. Additional details regarding the study and Charlotte Oral Surgery can be found at: www.charlotteoralsurgery.com
Charlotte (N.C.) Oral Surgery became one of three surgery centers across the U.S. to trial Zephyr Sleep Technologies’ Matrx plus oral appliance titration technology.
Here are five notes:
1. Matrx plus is an at-home device to help patient suffering from obstructive sleep apnea. The device is pending FDA clearance.
2. The study of Matrx plus is designed to prospectively evaluate and estimate the effectiveness of the oral appliance. The device allows dentists to collect sleep data in the patient’s home rather than at a sleep lab.
3. Zephyr Sleep Technologies is also studying the use of Matrx plus in more than 200 sleep labs and clinics across the U.S. To date, more than 10,000 tests have been completed.
4. The most common treatment for obstructive sleep apnea is continuous positive airway pressure. While this treatment is highly effective, patients report difficulty tolerating.
5. Charlotte Oral Surgery is certified by the American Academy of Sleep Medicine for providing oral appliance therapy.