For some obstructive sleep apnea (OSA) patients and their loved ones, a Continuous Positive Airway Pressure (C.P.A.P.) device is the therapy that brings quiet and refreshing sleep to everyone in the household. However, for others, C.P.A.P. brings to mind anything but blissful, comfortable rest, and instead, can result in many sleep disruptions including unwanted noise, pressure intolerance, mask irritation, claustrophobia, nasal congestion, dry mouth and more. It is estimated that more than 40% of patients refuse to wear it. Many have been reported to unconsciously remove their CPAP masks during the night in favor of a more dangerous night’s sleep, in which pauses of breath or shallow breaths due to airway muscle collapse, result in a lack of oxygen and intermittent wakings from sleep. This can lead to a host of ailments, including high blood pressure, stroke, diabetes, and depression.
While C.P.A.P. is the gold standard treatment for OSA, the risk of misuse or discontinued use has created an opportunity for innovators to search for a less intrusive way to treat it. The result is neuromodulation, and it is slated to take the sleep market by storm in 2018.
Companies are now marketing an implant that in which stimulation is used to open key airway muscles throughout the night. Controlled by a remote or wearable patch, these systems include a breathing sensor and a stimulation lead powered by a small battery. During sleep, the systems sense breathing patterns and deliver mild stimulation to the tongue and throat to keep the airway open. Surgery to implant these new sleep apnea devices is minimally invasive and exhibits short recovery time. Positive results from clinical testing of this therapy include high percent reductions in both apnea-hypopnea index (AHI), the marker of sleep apnea severity, and oxygen desaturation events from baseline.
With more than 21 million Americans that suffer from sleep apnea and do not seek treatment, neuromodulation is predicted to be the technology to deliver a better night’s sleep to more OSA patients and spouses, and healthier communities nationwide.
Where Are They Now
The most popular neuromodulation system to treat obstructive sleep apnea received FDA approval in 2014. Since then, the system has been made clinically available and is making its way into patients’ hands. Five-year results of the Clinical Trial evaluating the technology were released in 2018 and showed maintenance of the 79% reduction in apnea-hypopnea events, significant improvements in daytime functioning, and significant reductions in daytime sleepiness. The approval and use of neuromodulation for obstructive sleep apnea has led to treatment advancements in its less common counterpart, central sleep apnea. In October of 2017, the FDA approved the first implantable device for central sleep apnea further demonstrating the usefulness of this therapy.