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Technology and Mechanism of Action
Oral Pressure Therapy (OPT) is a new treatment for obstructive sleep apnea (OSA) that uses negative pressure in the mouth to shift the soft palate and tongue forward, improving airflow during sleep by relieving tissue obstruction in the airway. The negative pressure is created by a bedside console connected by a small tube to a mouthpiece worn inside the mouth during sleep. Unlike CPAP, Oral Pressure Therapy does not apply pressure directly to the airway, but applies light negative pressure in the oral cavity. With this system, the user breathes normally through the nose with the mouth closed. Unlike mandibular repositioning devices (also known as oral appliances and dental devices), Oral Pressure Therapy does not pull the lower jaw forward.

Clinical Studies
The ATLAST clinical trial demonstrated that Oral Pressure Therapy is effective and safe for the treatment of obstructive sleep apnea. Responders were easily identified, achieving a median AHI reduction from 26.2 to 5.7, compliance (continued use during the trial) was high, with high patient and bed partner satisfaction. 76% of responders report they would continue to use Oral Pressure Therapy to treat their OSA. Like other treatments for sleep apnea, a subset of trial participants did not respond to the therapy.

Contraindications
Oral Pressure Therapy should not be used by anyone who has a severe respiratory disorder (e.g., severe lung disease, pneumothorax), has loose teeth or advanced periodontal disease, or is under the age of 18.

Government Evaluation
One Oral Pressure Therapy medical device has been cleared by the FDA for sale with a prescription (the Winx Sleep Therapy System).