Loud snoring is not just a tiring irritation for partners but can also be a sign of sleep apnea. The National Institutes of Health reports that more than 12 million Americans suffer from the most common of the three varieties – obstructive sleep apnea, where the upper airway is repeatedly blocked during sleep. There are a number of treatment options already available and Minneapolis-based Inspire Medical Systems is about to add a shocking new addition to the treatment options on offer. The new system – which is about to enter clinical trials – electrically stimulates the nerve at the base of the tongue to keep it from blocking the air's journey to and from the lungs, and so offers the patient a good night's sleep.
An apneic can experience a cessation of airflow for more than ten seconds, but is generally partly awoken to take a breath. Even so, this lack of sound sleep can lead to other problems. Persistent oxygen starvation often results in daytime fatigue, lack of concentration and decreased alertness and can go on to increase the risk of heart attack and stroke. Depression, muscle pain, inefficient metabolism, diabetes, impotence and a host of other ailments are also associated with sleep apnea.
Existing TreatmentOne of the main causes of the most common variety of the condition – obstructive sleep apnea – is caused by the tongue and throat muscles becoming too relaxed and blocking the airway. Most sufferers are treated using a system known as continuous positive airway pressure (CPAP), where air is blown through the nose throughout the night and which can be very effective if used all the time. But such a system is not for everyone and studies have shown that the technique is often abandoned by a significant percentage of sufferers.
Upper Airway Stimulation therapyUsing well-established technologies from the fields of cardiac pacing and neurostimulation, Inspire Medical Systems has developed a system specifically to help those who are plagued by that troublesome tongue. The Upper Airway Stimulation (UAS) therapy stimulates the nerve that controls the base of the tongue with a small electrical pulse during sleep, to keep it toned and in place.
A pacemaker-like device is implanted under the skin, near the collarbone, and a wire is fed to the problematic twelfth cranial nerve. A sensor detects when the sufferer takes a breath and instructs the implant to stimulate the nerve. The system is adjusted so that the tongue receives just enough current to keep it from blocking the airway but not enough to disturb sleep (or result in any rude mid-snooze gestures) and a remote allows the patient to activate and deactivate the system. A timer can also be set so that the zapping is delayed until after the user is asleep.
Inspire Medical Systems' hypoglossal nerve stimulation technology has just recently been given the all-clear for Stimulation Therapy for Apnea Reduction pivotal clinical trials by the U.S. Food and Drug Administration (FDA) and will soon be heading to key sites throughout the U.S. and Europe. However, sufferers reading this might like to note that only those who tick all of the right boxes will be accepted into the trial, so cases where some other tissue causes the problem will not make it through. The results of the study will form the basis of a pre-market approval application to the FDA.