CHARLOTTE ORAL SURGERY SELECTED AS ONE OF THE FIRST THREE US CENTERS TO EVALUATE USE OF
MATRx plus TECHNOLOGY TO EFFECTIVELY DELIVER ORAL APPLIANCE THERAPY FOR
OBSTRUCTIVE SLEEP APNEA PATIENTS
CHARLOTTE, NORTH CAROLINA, FEBRUARY 5, 2018:
As one of only three participating centers nationwide (the only east coast participating location), and the only Oral &
Maxillofacial surgical facility nationwide, Charlotte Oral Surgery announces that it is joining centers in Los Angeles, California and Seattle, Washington in trialing the new MATRx plus™ oral appliance titration technology for use in different clinical environments.
The study involves the use of an at-home device (MATRx plus™) that is designed to prospectively evaluate and estimate the effectiveness of an oral appliance in patients who suffer from Obstructive Sleep Apnea (OSA) and are considering oral appliance therapy as a treatment. The device is pending FDA 513(f)(2) clearance, and intends to eliminate the costly and time-consuming fabrication of an oral appliance for patients who will not respond appropriately to this treatment. The in-use study involves evaluation of the device in an oral & maxillofacial surgical facility, including patient satisfaction and clinical benefit.
OSA is a chronic and common condition that is increasingly recognized as an important cause of medical morbidity and mortality. Evidence suggests that OSA may contribute to the development of systemic hypertension, neurocognitive dysfunction (including dementia), cardiovascular disease, and abnormalities in glucose metabolism. If left untreated, OSA may also lead to excessive daytime sleepiness, increased risk of motor vehicle accidents, impaired work performance, and decrements in healthrelated quality of life.
OSA is insidious and afflicted patients are often unaware of their symptoms. Common symptoms include loud snoring, observable breathing pauses during sleep, disrupted sleep quality, and excessive daytime sleepiness. Early recognition and appropriate therapy can minimize the health consequences and may improve performance of daily activities.
The most common nonsurgical treatment for OSA (besides weight loss) is continuous positive airway pressure (commonly known as CPAP), which is highly effective, but can be difficult to tolerate and comply with (particularly in patients with milder forms of OSA). The principal alternative to CPAP is oral appliance therapy, which is used to protrude the mandible during sleep, thereby opening the upper airway.
Oral appliances, while generally well-tolerated, are not always effective in eliminating OSA (each patient’s airway dynamics are unique). Uncertainty regarding the patient’s response to oral appliance 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. In addition, by avoiding fabrication of a device in those who are unable to be adequately titrated, significant cost savings are achieved.
Zephyr Sleep Technologies (Calgary, Alberta Canada) (a sponsor of the study) has developed a method for prospectively identifying those who will respond to oral appliance therapy. The current version of the technology, MATRx™, is deployed in over 200 sleep labs and clinics in the US and over 10,000 MATRx™ tests have been completed to date; however, MATRx use is limited to a sleep lab setting. As home sleep testing is becoming more common in the US, a new portable version of this technology (known as MATRx plus™) has been developed by Zephyr. The MATRx plus device allows healthcare professionals to collect sleep data in the patient’s home rather than in a sleep lab. Zephyr’s proprietary methodology and complex algorithms (using artificial intelligence) have allowed for testing in the comfort of the patient’s home.
Providing specialized Oral & Maxillofacial Surgical services, Charlotte Oral Surgery has a history, unique focus, and expertise in the 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. Charlotte Oral Surgery 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.
Contact Name: Leanne Drayton
Charlotte Oral Surgery
Phone Number: 704-358-8898