Sleep apnea sufferers who cannot tolerate or are poor candidates for CPAP therapy can now use an implantable neurostimulator device instead to stop snoring and get a good night’s sleep.
Obstructive sleep apnea affects millions of people worldwide, including one in three male adults in Saudi Arabia alone, according to one study.
This relatively common condition involves repeated interruption of breathing, or shallow breathing during sleep.
Sleep apnea has been linked to hypertension, stroke, heart attack, heart failure, arrhythmias, obesity and diabetes. It is also associated with excessive daytime sleepiness, fatigue and consequent driving or workplace accidents.
The standard treatment is CPAP or continuous positive airway pressure, where a machine delivers constant air pressure through a mask worn over the nose while sleeping.
The positive pressure maintains a patent airway by preventing the collapse of the tongue and throat muscles. Blockage of the air passages cause the snoring and irregular breathing patterns in sleep apnea.
While effective, CPAP is not tolerated well by half of patients who find it cumbersome or suffocating. The poor compliance among patients has researchers thinking of more acceptable treatments.
The U.S. Food and Drug Administration recently approved of a first-of-its-kind device that may just be the solution.
The Inspire Upper Airway Stimulation (UAS) device is a fully implantable neurostimulator proven to effectively treat obstructive sleep apnea.
The pacemaker-like device consists of a pulse generator implanted in the chest. The generator has two leads:
- A sensing lead that runs to the chest to monitor respirations
- A stimulation lead runs up the throat to a branch of the hypoglossal nerve to deliver mild stimulation that keeps the upper airways open.
A small handheld remote turns the device on when it’s time to sleep and off upon waking.
“The FDA approval of Inspire therapy represents a new era of choice for a subset of patients with moderate to severe obstructive sleep apnea who are unable to use CPAP,”
Tim Herbert, president and chief executive officer, Inspire Medical Systems, said in a statement.
“All of us at Inspire Medical Systems are committed to improving the health and quality of life for these individuals with OSA, and we are excited to make this innovative and much needed treatment available to patients and physicians,”
The company said that unlike surgery, the device preserves the natural airway and facial anatomy.
It claims the device has been effective at treating sleep apnea, citing a study published in The New England Journal of Medicine entitled “Upper-Airway Stimulation for Obstructive Sleep Apnea / STAR (Stimulation Therapy for Apnea Reduction) Trial.”
In the study involving 126 participants, the device reduced apnea events by 68 percent and oxygen desaturation by 70 percent.
"This therapy represents a major advance in sleep apnea treatment for some patients who are unable to use or tolerate CPAP therapy,"
Meir Kryger, MD, professor, Yale School of Medicine, said in a statement.
"Patients with moderate to severe OSA who are not on effective treatment are at an increased risk for cardiovascular disease, accidents and death. There is a significant need for safe, effective and well-tolerated new treatments in the sleep medicine field,"
Sleep deprived people, including what one study estimates to be millions living in Arab countries who have obstructive sleep apnea, and who find it difficult to make lifestyle changes, use breathing devices, or undergo surgery, can now opt for this less invasive therapy.