Snoring is the sound you make when your breathing is blocked while you are asleep. The sound is caused by tissues at the top of your airway that strike each other and vibrate. Snoring is common, especially among older people and people who are overweight.

When severe, snoring can cause frequent awakenings at night and daytime sleepiness. It can disrupt your bed partner's sleep. Snoring can also be a sign of a serious sleep disorder called sleep apnea. You should see your health care provider if you are often tired during the day, don't feel that you sleep well, or wake up gasping.

To reduce snoring

• Lose weight if you are overweight. It may help, but thin people can snore, too.
• Cut down or avoid alcohol and other sedatives at bedtime
• Don't sleep flat on your back

Mouth The mouth includes the lips, tongue, palate, gums, and teeth.

A fleshy bead of tissue called the uvula drops down from the center of the posterior edge of the soft palate. Although some have suggested that the uvula is a vestigial organ, it serves an important purpose. When you swallow, the soft palate and uvula move upward, helping to keep foods and liquid from entering the nasal cavity. Unfortunately, it can also contribute to the sound produced by snoring.

The act of snoring, by itself, is often harmless. However, in some people, it can signal a life-threatening disorder called sleep apnea. Sleep apnea causes pauses in your breathing that can last for seconds or minutes, dozens of times each hour. These pauses disrupt your sleep and cause you to wake up or sleep only lightly, which can make you feel extremely tired during the day. The pauses also reduce the amount of oxygen in your blood and can cause damage to the heart and blood vessels, which increases the risk of heart disease. Sleep apnea also increases the risk for high blood pressure, stroke, and diabetes.

Fortunately, sleep apnea is treatable. People who snore loudly, have pauses in breathing during sleep, and feel very tired during the day should speak with a healthcare provider.

Sleep apnea is defined by episodes during which a sleeper’s breathing stops. These episodes can last 10–20 seconds or longer and often are associated with brief periods of arousal. While individuals suffering from sleep apnea may not be aware of these repeated disruptions in sleep, they do experience increased levels of fatigue. Many individuals diagnosed with sleep apnea first seek treatment because their sleeping partners indicate that they snore loudly and/or stop breathing for extended periods of time while sleeping (Henry & Rosenthal, 2013). Sleep apnea is much more common in overweight people and is often associated with loud snoring.

FDA Authorizes Marketing of Novel Device to Reduce Snoring and Mild Obstructive Sleep Apnea in Patients 18 Years and Older

Today, the U.S. Food and Drug Administration authorized marketing of a new prescription only device intended to reduce snoring and mild obstructive sleep apnea. Unlike devices used while patients sleep, this is the first device used while awake that is intended to improve tongue muscle function, which in time can help prevent the tongue from collapsing backwards and obstructing the airway during sleep.

“Obstructive sleep apnea not only impacts sleep quality, but can have other serious health impacts if untreated. Today’s authorization offers a new option for the thousands of individuals who experience snoring or mild sleep apnea,” said Malvina Eydelman, MD., director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices in the FDA’s Center for Devices and Radiological Health.

Obstructive sleep apnea (OSA) is a prevalent sleep-disordered breathing with potential serious long-term effects. It can occur when the upper airway becomes blocked repeatedly during sleep, reducing or completely stopping airflow. Untreated OSA can lead to serious complications such as heart attack, glaucoma, diabetes, cancer and cognitive and behavioral disorders. OSA is categorized by the number of apneas (pauses in breathing) plus the number of hypopneas (periods of shallow breathing) that occur, on average, each hour. This number, called the Apnea-Hypopnea Index (AHI) measures the severity of OSA. Mild OSA is defined as an AHI score of more than five but less than 15. The device, the eXciteOSA, is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the tongue in order to reduce snoring and mild sleep apnea for patients who are 18 years or older.

The eXciteOSA device works by delivering electrical muscle stimulation through a mouthpiece that sits around the tongue. The eXciteOSA mouthpiece has four electrodes, two located above the tongue and two located below the tongue. The device provides electrical muscle stimulation action in sessions that consist of a series of electrical pulses with rest periods in between. It is used for 20 minutes once a day during a wakeful state, for a period of 6‐weeks, and once a week thereafter.

The FDA assessed the safety and effectiveness of the eXciteOSA device in 115 patients with snoring, including 48 patients with snoring and mild sleep apnea. All patients used the device for 20 minutes, once a day for 6 weeks, then discontinued use for 2 weeks before they were reassessed. Overall, the percent of time spent snoring at levels louder than 40dB was reduced by more than 20% in 87 out of the 115 patients. In a 48-patient subset with snoring and mild OSA, the average AHI reduced by 48%, from 10.21 to 5.27, in 41 out of 48 patients. The most common adverse events observed were excessive salivation, tongue or tooth discomfort, tongue tingling, dental filling sensitivity, metallic taste, gagging and tight jaw.

Patients should receive a comprehensive dental examination prior to use of the device. The eXciteOSA device is contraindicated for patients with pacemakers or implanted pacing leads (electrodes); patients with temporary or permanent implants, dental braces, intraoral metal prosthesis/restorations/appliances or dental jewelry in the mouth; patients who are pregnant or may be pregnant; or patients suffering from ulcerations in or around the mouth. The eXciteOSA device is not intended for patients who have or are suspected of having OSA with an AHI of 15 and higher.

The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. This means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket notification process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type.

The FDA granted the marketing authorization to Signifier Medical Technologies, LLC.