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Apnex Hypoglossal Nerve Stimulation System
#11
RE: Apnex Hypoglossal Nerve Stimulation System
(05-09-2012, 08:38 PM)JJJ Wrote:
(05-09-2012, 06:49 PM)PaulaO2 Wrote: So your tongue will be twitching with every breath???
That's going to take some getting used to.

I'd be very interested in comments and interviews with people who have undergone the procedure. And I mean real people on a public forum like this where people can ask questions and get answers, not snips cut out of context for a press release.

I'd also like to see some scientific data on the efficacy. There are so many causes for sleep apnea; does this procedure work better for some than others? Thinking-about
Me too bc they say "All studies, including this one, involve some risk (complications or side effects from the study treatment), some of which can be serious" but they don,t say what are the complications or the risks.

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#12
RE: Apnex Hypoglossal Nerve Stimulation System
Well, there's the body reacting to the device (such as allergies/sensitivites to metals/plastics or a hyper-immune system).

There's the wire with the same issues.

Then there's the whole "electric current directly to a nerve" issue.

And it is a surgical procedure with all the usual risks involved in that.

I would assume they would snake something down from the neck, snag the cable, then bring it up. And repeat for the chest one. The wires they use for such things are very, very small. It wouldn't be like, 14 gauge!

I would ask how it effects the saliva glands and what else that nerve is responsible for.

It is not just the tongue that blocks the airway but it is a huge part of it.

This could be a huge positive step forward in CPAP treatment.
PaulaO

Take a deep breath and count to zen.




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#13
RE: Apnex Hypoglossal Nerve Stimulation System
Quote:I'd be very interested in comments and interviews with people who have undergone the procedure. And I mean real people on a public forum like this where people can ask questions and get answers, not snips cut out of context for a press release.

No problem. I am in the study right now. I have yet to get the procedure done as I am still in the screening phase. If everything goes well I should prolly have the HGNS by the beginning of July.

Quote:So the wire from the machine in your chest goes outside the body up to the jawline?

No, the wire is completely on the inside. Yes they do some kind of snag thing and pull the wire to where it needs to be. From what I've been told so far, out of the 82 people so far that has had this procedure done you can't tell that someone has this. They have told me that on most people you can not even see where the machine is in there chest. They have told me that on a couple of people who where quite skinny that you could see a bulge in there chest but not that actual outline of the device. More like a swollen area in the chest. They said that these two people were rather skinny and they had virtually no fat to for the "pocket" which has the machine to hide.

I don't know exactly when they started here but I do know that it is still in its first year here in the states. So pretty much still have the 5 years of study left. Keep in mind that even after the 5 years, if FDA approves it, there still has to be a work out between APNEX and the insurance companies. Who knows how long that would take.

Quote:I'd also like to see some scientific data on the efficacy. There are so many causes for sleep apnea; does this procedure work better for some than others?

I don't have the charts that they showed me last week during the information session. I did however right some numbers down. From the Australia study (which is the only study that has been completed so far) they implanted 32 people. These 32 people had an mean of 37 apneas per hour. After the implant there was a mean of 8 apneas per hour. Doctors say anything less than 10 apneas an hour is considered normal. They were also successful on the energy chart, meaning they had more energy afterwards.

I don't know the qualification for being accepted in Australia but I know here they are not accepting for the study people that have more than a BMI of 28. Also you have to have between 20 and 78 apneas an hour. They are also doing a nasal endoscopy to see if this procedure will benefit you.

Quote:does this procedure work better for some than others

That we will have to wait and see I suppose.

Quote:Me too bc they say "All studies, including this one, involve some risk (complications or side effects from the study treatment), some of which can be serious" but they don,t say what are the complications or the risks.

They gave me a list of the risks and side effects. The doctor running this study at my hospital and the surgeon where there. They both agreed that the biggest worry and risk they have is the anesthesia. With any surgery that is always one of the biggest risk. Second risk would be infection. They stressed that that is a risk but they were worried about that at all. The equipment is specifically designed for no allergic stuff. The procedure you stay in the hospital for observation so if there is a start of an infection they catch it and take care of it. With anything involving surgery there is a risk of infection, that is why the operating rooms are so clean. As far as side effects: when waking your tongue can feel a bit sore from moving forward when your not used to it, but in the 82 people so far the soreness went away in the first hour of waking, and then after a couple week they weren't sore anymore as their muscle got used to the movement. Also you can rub your tongue on your teeth causing a sore area on your tongue. If this happens APNEX will pay for a dentist to see if there is something with your teeth causing this ie. a burr or something where the dentist can fix this problem and/or getting some kind of a bite plate or guard to stop your tongue from rubbing on your teeth. From my understanding there has only been a couple people so far that had an issue with that and after the dentist visit it was fixed.

I think that is an overview. I don't have my notes with me right now. I do have all the information and stuff they gave me. Maybe an upload in pdf in the future?

This is a positive step forward is OSD treatment. It is another option that everyone with OSD will have. Right now there is only bite plate and CPAP/BIPAP. I know this will scare some and that it wouldn't be for everyone, but to be able to have options with treatment is wonderful.

All for now. I will keep you guys updated and feel free to ask me questions. I'll do my best to answer them or simply tell you I don't know.
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#14
RE: Apnex Hypoglossal Nerve Stimulation System
For info on this treatment go to [link removed]. Interesting to hear how well it works.

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To maintain our status as an educational organization, the only commercial links allowed in this forum are to CPAP-related manufacturer websites. This is stated in the Apnea Board Rules with details given in the Commercial Links Policy section.
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#15
RE: Apnex Hypoglossal Nerve Stimulation System
Moderator's Note:

If anyone wants to read about it, do a Google search for the text he used in his subject line.

PaulaO

Take a deep breath and count to zen.




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#16
Exclaimation 
RE: Apnex Hypoglossal Nerve Stimulation System

Hi, I am curious about the interaction of HGNS (Apnex, Inspire) devices with MMA surgery and wonder if anyone has any experience with 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, if one has mild to moderate OSA (AHI around 20)?

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). 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)?
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#17
RE: Apnex Hypoglossal Nerve Stimulation System
This therapy certainly sounds interesting.

However, I'm curious why is it so difficult to implement a device that holds the tongue from falling back during sleep? Something that has an elastic pull to it would allow a person to still move the tongue around in a limited way, but during sleep it would give the extra support to keep it from falling back into the throat opening.

I tried an experiment sitting in a chair with my head straight - a normal sitting position. While breathing in through the mouth, I can go from a normal tongue position (full airflow) and slowly pull it back until the airway is completely closed off. It doesn't take all that much movement to seal the throat off.

Obviously, grabbing/holding the tongue in place with a soft device (like soft neoprene used on masks?) and having a person handle the psychological effects would be the challenge.

Otherwise, why has this simple solution and therapy failed to work?

Tom

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#18
RE: Apnex Hypoglossal Nerve Stimulation System
I had the APNEX device implanted in January and just completed my six month study. All is perfect and I am sleeping like a baby. I also have energy all day long! Best decision I ever made. If anyone has questions, please feel to contact me or ask questions here.

Best regards,

Jeanne
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#19
RE: Apnex Hypoglossal Nerve Stimulation System
(07-29-2012, 07:30 PM)Jeanne Lynne Wrote: I had the APNEX device implanted in January and just completed my six month study. All is perfect and I am sleeping like a baby. I also have energy all day long! Best decision I ever made. If anyone has questions, please feel to contact me or ask questions here.

I have a few questions.

1) I understand there is a pacemaker-type device that sends the currents up the wire to stimulate the throat muscles. Is this device implanted under the skin? What does it use for a power supply and how long does it last?

2) What happened during the six month study? Were you monitored like in a sleep lab? Every night, or periodically, or how often?

3) Do you recall how severe your sleep apnea was before the procedure, like AHI numbers from previous sleep studies? And do you have numbers for what it is now after the procedure?

Thanks for posting about your experience. I know a lot of people are interested in the APNEX device.
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#20
RE: Apnex Hypoglossal Nerve Stimulation System
(07-07-2012, 03:02 PM)Tommy C Wrote: This therapy certainly sounds interesting.

However, I'm curious why is it so difficult to implement a device that holds the tongue from falling back during sleep? Something that has an elastic pull to it would allow a person to still move the tongue around in a limited way, but during sleep it would give the extra support to keep it from falling back into the throat opening.

I tried an experiment sitting in a chair with my head straight - a normal sitting position. While breathing in through the mouth, I can go from a normal tongue position (full airflow) and slowly pull it back until the airway is completely closed off. It doesn't take all that much movement to seal the throat off.

Obviously, grabbing/holding the tongue in place with a soft device (like soft neoprene used on masks?) and having a person handle the psychological effects would be the challenge.

Otherwise, why has this simple solution and therapy failed to work?

Tom

There are a few devices that do this. The one I have seen the most has a padded hook thing that goes to the back of the throat and holds the tongue in place. I am gagging just thinking of it. I would think this would be the biggest drawback.

PaulaO

Take a deep breath and count to zen.




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