Stevenson Industries, which for over 15 years has manufactured the CPAP Pro, a CPAP delivery interface without straps or headgear, has received FDA clearance for SleepSaver, a mouth-securing device for open mouth breathers who use CPAP.

SleepSaver gives mouth-breathing patients an option beyond chinstraps and full-face masks, Stevenson Industries says.

The SleepSaver utilizes an upper and lower boil and bite mouthpiece that is easily made in the patient’s home. Its “slip-fit” design allows for slight forward and lateral movement of the jaw, greatly improving sleep comfort without losing the necessary closed mouth seal.

“I often deal with patients who have difficulty tolerating nasal CPAP therapy due to inadvertent mouth opening during periods of sleep,” says Dr Daniel Norman, diplomate, American Board of Sleep Medicine, in a release. “To date, the options that I have available in these cases are the use of chinstraps or adhesive products to keep the mouth closed. Chinstraps are sometimes uncomfortable, bulky, and may irritate the skin. The SleepSaver mouthpiece is simple in its design, avoids the issues described [above] that are associated with the alternatives listed, and achieves a similar goal in discouraging mouth opening with a nasal mask.”

The SleepSaver is designed to work comfortably with most of the minimally invasive nasal interfaces currently on the market. It’s available by prescription through sleep apnea equipment providers nationwide.