Some 800,000 people in the U.S. are diagnosed each year with obstructive sleep apnea, in which the tongue relaxes during the onset of sleep to the point of physically blocking much of the upper airway. The condition often causes repeated interruptions of sleep, which can lead to increased blood pressure, coronary problems, and diabetes.
The established treatment is a respirator-like gadget that a patient is supposed to wear while sleeping. But nearly half of the people who are directed by their doctors to use these “continuous positive airway pressure,” or CPAP, devices simply can’t or won’t comply, according to Terry Davidson, a professor of head and neck surgery at the UC San Diego School of Medicine. Davidson says he also is pessimistic about surgeries that are intended to move the tongue forward and away from the throat.
A San Diego medical device startup where Davidson is Chief Medical Officer is now testing a new approach, which uses an implanted electronic device to transmit low-current neurostimulation to the tongue. The steady electric current causes the tongue muscle to tighten, so it pulls away from the upper airway. The company, ImThera Medical, announced in December that it had implanted its technology in two obstructive sleep apnea patients in Belgium.
Marcelo Lima, ImThera’s founding chairman and CEO, tells me he views the non-compliant CPAP patients as an ideal market for ImThera’s technology. The company is in clinical trials only in Europe, and intends to implant devices in 10 more patients as part of those studies. In the European trials, a surgeon implants ImThera’s pacemaker-like device in the upper chest, just under the skin, and extends a wire to a multi-contact electrode in the jaw. From there, the surgeon attaches the electrodes to the hypoglossal nerve, which controls multiple muscles of the tongue. The company has posted a YouTube video that explains it all here.
The implanted electronic device is programmed a couple of weeks following the surgery to send just enough electricity to the nerve to deliver what Lima calls “awake muscle tone to the sleeping tongue.” A handheld radio-frequency wand is used to turn