Under development: hypoglossal neurostimulation implants to treat sleep apnea

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For every person who enjoys success with the use of CPAP to treat their obstructive sleep apnea, there is yet another person who, for a wide variety of reasons, has not been able to make CPAP work for them.

Fortunately, those who are unable to use CPAP aren’t without options. Most are aware of alternatives such as surgical procedures or oral devices as options for treating sleep apnea.

But what about mild neurostimulation from an implant?

What is THN sleep therapy?

THN stands for Targeted Hypoglossal Neurostimulation, a new therapy for sleep apnea created by San Diego-based developer, ImThera Medical. The therapy itself is composed of:

  • a pulse generator (or “pacemaker”) that is implanted in the upper part of the chest
  • a small electrode attached to the pacemaker and positioned to interact with the hypoglossal nerve (also implanted), and
  • an external remote control to activate the therapy

ImThera implant illustrationThis particular neurostimulation implant is used to stimulate the activity of the hypoglossal nerve, which supports the activity of the tongue.

This stimulation improves the muscle tone in the tongue as well as the tone of the soft tissues adjacent to it.

For some people, the tongue is known to relax and collapse into the upper airway as they sleep, leading to obstructive sleep apnea (OSA).

By keeping the tongue from fully relaxing, THN endeavors to prevent obstructions in the upper airway during sleep.

Other implantable therapies for sleep apnea

ImThera Medical is not the first developer to bring a neurostimulation technology to sleep apnea therapeutics.

Inspire Medical Systems launched a similar device in May 2014 using their patented Upper Airway Stimulation (UAS) therapy to treat obstructive sleep apnea.

Minnesota developer Respicardia is working on a transvenous neurostimulation therapy called the remedē® System which specifically targets those patients with central sleep apnea (CSA).

Another company, Nyxoah SA, raised $20 million last year to develop their own neurostimulation implant, known as the Genio™ system.

Why not just use CPAP for sleep apnea?

There’s an ongoing need for alternatives to traditional therapies to treat OSA, like continuous positive airway pressure (CPAP). Many people cannot use PAP options due to other medical conditions, or they may not be able to tolerate it well enough to remain adherent to their therapy.

Remaining on one’s sleep apnea treatment is not just an ideal goal, but a practical necessity in today’s healthcare environment.

The addition of a new implantable therapy may make a life-or-death difference for patients with stubborn OSA who have not found relief from CPAP, oral devices, or surgical procedures.

Is ImThera’s THN sleep therapy available now?

Not at this time. The therapy continues to be tested for efficacy and, as such, is considered “under investigation” by the FDA, which approved clinical trials for the device back in 2014. You can read more about the findings from research thus far here:

Laryngoscope, November 2016: “Targeted hypoglossal nerve stimulation for the treatment of obstructive sleep apnea: Six-month results.”
European Respiratory Journal, February 2013: “Targeted hypoglossal neurostimulation for obstructive sleep apnoea: a 1-year pilot study.”