Hypoglossal Nerve Stimulation System

VVV, you're right that OSA can be caused by various reasons, narrow airways being one of them. I've been told that part of the selection criteria will be having an endoscopy, probably for that very reason.

Mary Z, I will give updates, depending on how far I get. I've been sent 18 pages of information (rather daunting) and will have a telephone interview with someone this week before I progress onto the next stage.

Jandi, yes, I've heard it compared to a pacemaker in size. It seems to be placed on the right-hand side on the upper chest. You seem to be doing well with CPAP. My AHA is also moderate at 23 and the lady told me that is lower than they usually have but there's no reason that would be a hindering factor. However, from what I've read, they usually want people for whom CPAP hasn't been an workable option. In my case, I'm a stomach sleeper and I hated CPAP. Tried it for two months and felt worse every morning. However, you should ring and speak to them to see what they say.

Chunkyfrog, during the trials there is obviously no cost whatsoever. In fact, during the four or five years of testing and follow-ups, the participants will get the best of medical supervision and care. I don't know what the cost will be once they are released to the general public ..... as that won't be for four or five years, maybe we should start saving now!

Hi, I am curious about the interaction of HGNS (Apnex, Inspire) devices with MMA surgery and if anyone has any experience or insights on that.

I'm wondering if MMA can still be done after an HGNS device is implanted if it is not successful. Conversely can HGNS be effectively used after MMA? I am wondering if there are clinical reasons that either approach should or could preclude the other in terms of scar tissue, physiological results etc.? Which should one pursue first, MMA or HGNS, in patients with mild to moderate OSA?

Unfortunately I believe that currently in the USA for research purposes clinical trials for HGNS require that the patient has not undertaken MMA surgery to that point (this is an exclusion criteria). I suspect this it to reduce the number of confounding variables.

However I believe that these devices are approved in Europe so I wonder if it might be possible for a US citizen to travel there to get them if they didn't qualify for a clinical study here due to prior MMA or want to wait until they are approved by the FDA (probably a long time)?

I'd be very careful about MMA surgery (along with UPPP) because things tend to revert to their previous state within a few months to a year, and the nerve stim is so new here that I doubt many (if any) on the forum have had it at all. I would research the heck out of everything, including positional apnea if I was diagnosed with a mild condition - you might not even need cpap at all if it turns out that position makes enough of a difference for you, after proper testing with a new sleep study and routine oximetry...

viewtopic/t79383/viewtopic.php?f=1&t=70 ... py#p656886

http://www.ncbi.nlm.nih.gov/pubmed/20572416

Julie wrote:I'd be very careful about MMA surgery because things tend to revert to their previous state within a few months to a year,

Sorry Julie, But that is incorrect. Metal plates are surgically implanted on each side to permanently hold the jaw forward - will never revert.

Anthromed on Sat Jul 07, 2012 11:31 am

I'm wondering if MMA can still be done

What is your age?

Sorry! Was thinking about something else!

I know this subject has been spoken about previously, however, I was wondering if anyone here has actually taken part in trials?

I have the paperwork for it and am reviewing it now. I met all of the initial screening requirements but there are several more to go. I am still mulling it over and really haven't made up my mind. It is still very much on the table for me and I feel very educated about it after the meeting w/ the trial folks.

I will say that my gut feeling now is that MMA seems more appealing long-term. I am going to follow up on MMA as well over the next couple of weeks, lay out all of the options, do a pro/con, and see what looks like the best way to go. So I'll update this thread as I go. I can probably answer general questions since I have talked w/ the folks directly.

What is your age?

Late 30's.

Anthro, I'll try to take what I know for sure from talking w/ the trial folks and answer. It won't be gospel but might help a bit.

I'm wondering if MMA can still be done after an HGNS device is implanted if it is not successful.

I am not sure but I can say for sure you CAN'T have any other treatment of any kind during the trial, which is 5 years. So basically, if you decide to go through w/ the HGNS trial, you would have to use it and it alone. This includes PAP, MMA, oral appliance, positional therapy, etc.

From looking at the packet and talking w/ the trial people, I don't see any reason why you couldn't do MMA after the HGNS trial. The kicker w/ HGNS is that so far the rate of success hasn't been all that great - only around 50% reduction in AHI. That isn't much better than an oral appliance. For MMA, it appears that there is a very much higher rate of actual success, in some cases curing apnea. I can just tell you from my research, MMA seems like a much better long term solution and seems like a good first choice for me. It does scare me quite a bit because of the potential for nerve damage and teeth issues, but otherwise it seems like a good option. From what I can tell, the majority of people who have it are happy they did.

HGNS is so new it is hard to say the long term issues. I do know that the idea of damaging my tongue nerve is probably one of the scariest possible side effects. I do believe that this type of approach will ultimately be a very good treatment, just not sure we are there yet.

I am wondering if there are clinical reasons that either approach should or could preclude the other in terms of scar tissue, physiological results etc.? Which should one pursue first, MMA or HGNS, in patients with mild to moderate OSA?

This is a good question. The only stats I have seen on why HGNS is not as successful in some is BMI > 35. I am not sure if MMA has those same types of BMI ranges as a factor. Again, for me MMA seems like a better option because it has a higher success rate.

themonk wrote:Anthro, I'll try to take what I know for sure from talking w/ the trial folks and answer. It won't be gospel but might help a bit.

I'm wondering if MMA can still be done after an HGNS device is implanted if it is not successful.

I am not sure but I can say for sure you CAN'T have any other treatment of any kind during the trial, which is 5 years. So basically, if you decide to go through w/ the HGNS trial, you would have to use it and it alone. This includes PAP, MMA, oral appliance, positional therapy, etc.

From looking at the packet and talking w/ the trial people, I don't see any reason why you couldn't do MMA after the HGNS trial. The kicker w/ HGNS is that so far the rate of success hasn't been all that great - only around 50% reduction in AHI. That isn't much better than an oral appliance. For MMA, it appears that there is a very much higher rate of actual success, in some cases curing apnea. I can just tell you from my research, MMA seems like a much better long term solution and seems like a good first choice for me. It does scare me quite a bit because of the potential for nerve damage and teeth issues, but otherwise it seems like a good option. From what I can tell, the majority of people who have it are happy they did.

HGNS is so new it is hard to say the long term issues. I do know that the idea of damaging my tongue nerve is probably one of the scariest possible side effects. I do believe that this type of approach will ultimately be a very good treatment, just not sure we are there yet.

I am wondering if there are clinical reasons that either approach should or could preclude the other in terms of scar tissue, physiological results etc.? Which should one pursue first, MMA or HGNS, in patients with mild to moderate OSA?

This is a good question. The only stats I have seen on why HGNS is not as successful in some is BMI > 35. I am not sure if MMA has those same types of BMI ranges as a factor. Again, for me MMA seems like a better option because it has a higher success rate.

Hi Monk,

Thanks for this detailed response.

In terms of sequencing I guess a person would have to weigh whether they want to try the HGNS with a slightly lower risk profile than MMA but perhaps slightly reduced therapeutic potential. If I understood it correctly once you do MMA you cannot do the current HGNS trials. As you note you during the trial you cannot use other devices (CPAP, MAD) unless you drop out and have it removed, which is another major surgery.

In terms of BMI, I too have read that in the website materials and there is a large impact of just slight increases in BMI on the potential of the treatment to reduce the AHI.

On the other hand, because HGNS device companies are screening out higher BMI patients, they believe they can increase the efficacy in these pivotal trials (>50% reduction) because in earlier studies a few higher BMI individuals with worse outcomes skewed the results. In fact, I believe another exclusion criteria is based on the BMI. In many cases therefore I agree that MMA could be better for people with higher BMI for example.

Also, a consideration is that if I understand correctly MMA can result in immediate reduction in BMI which also helps the therapeutic outcome and AHI because one has their mouth wired shut for a month and lives on a liquid diet.