New Sleep Apnea Treatment: Hypoglossal Nerve Stimulation

Here’s a radically new approach to treating obstructive sleep apnea: hypoglossal nerve stimulation. I read about initial successful pilot studies many years ago out of Johns Hopkins, but thought the concept never took off since I didn’t hear anything more. I was wrong. ImThera recently announced their aura6000 Targeted Hypoglossal Neurostimulation (THN) device for obstructive sleep apnea at the Annual Meeting of the American Academy of Otolaryngology – Head & Neck Surgery in San Diego last month. There are two other companies rushing to come out with similar products. Apnex is one company and Inspire is another.

 

It turns out that this company’s been busy developing this product and is about to undergo clinical trials in Europe before trying it out here the US. The technology’s not new—it’s basically a nerve stimulation device that’s been used on other areas of the body before. In this case, activation of the rib cage muscles causes the device to stimulate the hypoglossal nerve, which tenses the genioglossus muscle of the tongue.

 

During non-REM deep sleep, all the muscles in the body relax partially, whereas in REM sleep, all the muscles are relaxed completely. In sleep apnea patients, this partial and total muscle relaxation leads to repeated obstructions and arousals. By sensing that the ribs are moving, it stimulates the tongue muscle, preventing eventual collapse of the throat tissues.

 

In the original Johns Hopkins article from 2001, eight patients underwent this procedures on one side of the tongue, and the AHI dropped from 52.0 to 22.6 in non REM sleep and 48.2 to 16.6 in REM sleep. The final results aren’t great, but significantly improved. Additional procedures may need to be performed, since the tongue isn’t the only area of obstruction.

 

If this procedure became available in the US, would you consider undergoing this procedure? Please enter your answers below in the comments box.

 

Please note: I reserve the right to delete comments that are offensive or off-topic.

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14 thoughts on “New Sleep Apnea Treatment: Hypoglossal Nerve Stimulation

  1. Just to clarify…the nerve stimulation treatment would be an ongoing lifelong intervention (similar to the use of CPAP)?

  2. I would not consider the procedure because the results are poor. Maybe the procedure would lower my AHI to 20.0. I know from my own experience that life is miserable with an AHI of 20.0 and your health is being slowly destroyed.

    My AHI is 57.0 without CPAP and around 1.0 with CPAP. If I have problems with CPAP and my AHI moves up to anything above 3.0 or so, I feel very tired and sleepy the entire day. It makes sense if you consider that an AHI of 3.0 over seven hours of sleeping, means 21 awakenings and maybe 21 oxygen desaturations plus unhealthy increases in cortisol and adrenaline.

    I was first excited when these devices were announced, but now I am skeptical that they will ever be very effective.

  3. Just wondered whether the AHI was lowered without lowering the totalnumber of arousals from sleep? That is, did the stimulation of the hypoglossal nerve disrupt the patients sleep in and of itself? I think it's important to lower the AHI, obviously. But if a treatment creates arousals of a different type, then the patients' sleep won't be any more restful. Any idea whether this data is available Dr. Park? Thanks for sharing this research.

  4. Ann, that's great question. I don't remember from the paper if arousals were mentioned, but subjective results were generally positive. Any device, whether a nerve stimulator, oral appliance or CPAP, will cause increased arousals. These are questions that will be answered more fully in the initial upcoming clinical trials.

  5. Does it require an intrusive procedure to "plant" the stimulant?  I always wonder why someone hasn't think of this and I am willing to give it a try.  Since I can't live with my CPAP machine (it feels like a spider on my face and somehow it creates a throat drying airflow with my anatomy) so for me some help is better than no help at all. 

  6. Mr. Lui,

    It's like a pacemeker, but with leads that go to one side of your neck to stimulate the nerve that goes to your tongue and other leads that go to your lower rib cage. If you're interested, please visit Apnexmedical.com for more information. There are a number of rigid inclusion criteria. If you're in the NY metro area, you're welcome to see me for a consultation.

  7. Sounds interesting. Last night my breathing was so shallow that I couldnt sleep with or without the CPAP machine/ I'm not sure what will help me….

  8. I’m having trouble tolerating my CPAP (nose, sinus, dry mouth, burning lungs). My ENT is recommending septoplasty, tubinate reduction, and UP3. It’s got me scared.

    The pacemaker requires an incision somewhere on the chest, correct? Is another incision required on the neck to place the electrode for the hypoglossal nerve? Are the electrode wires ‘snaked’ under the skin from the implant to the nerve, or does it require a continuous incision?

    Given how the CPAP has negatively impacted my quality of life, and the frightening possibilities of the UP3, I think I’ll at least investigate this.

  9. Mr. Harkins, there’s a small incision under the chin, and another on just below the collar bone for the “pacemaker.” Leads are tunneled under the skin from the nerve to the controller, as well as for the chest sensors. If you’re interested in this study, take a look at the Apnex site.

  10. Is a soft-palate version of this technique plausible? Are the nerves that control the soft palate surgically accessible and would there be any place to implant the battery and pulse generator?

  11. Mr. Newmark,

    The soft palate has multiple nerves that control movement, unlike the tongue which has one (but many different branches). Although technically possible, palatal nerve stimulation can be challenging. In addition, years of snoring vibrations and tissue loosening won’t be able to be properly addressed by nerve and muscle stimulation.

    Only time will tell if the tongue nerve option ever makes it to receive FDA approval, and whether it takes off as an alternative to CPAP. My guess is that it will serve a very small segment of the sleep apnea population and that CPAP will remain the dominant option.

  12. My poor sleep started in my early teens and continually deteriorated over time along with my health. I had no recollection of what feeling well rested, alert and productive throughout the day was. Where was I functioning relative to my potential? Poor sleep complaints to doctors were dismissed as stress, depression etc to be medicated away.

    In my opinion anyone who is prescribed antidepressants or sleeping pills should be required to have their sleep evaluated by a qualified professional.

    An invasive medical procedure or the stigma of having to use an implanted medical device will undoubtedly make anyone apprehensive. But maybe you had some of the same thoughts or feelings when someone said you need a machine to breath, CPAP? Keep an open mind and find something that works and you’ll consistently use.

  13. On one of my medical websites, they are promoting the Inspire version. They are very sneaky about not telling people how much surgery this will require, the problems with infections and required maintenance. I would have to be really bad off to even consider this. I greatly prefer CPAP.