"please keep me updated about oximeters "
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New Innovative Clinical Trial for Sleep Apnea
For most people with obstructive sleep apnea, CPAP and oral devices work very well. However, some people can't tolerate or benefit from these two options. For these people, surgery may be another option.
There are numerous types of surgical procedures for obstructive sleep apnea. The more useful ones involve modifying the breathing space behind the tongue. Clinical trials have now begun testing a new way of treating tongue collapse, using a nerve stimulator based on pacemaker technology. I'm honored to be part of an innovative, IRB approved, national multi-site study of this investigational device. Please take a look at this brochure for more information.
Please contact me if you have any questions @ doctorpark@doctorstevenpark.com.
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Permalink Reply by Mary Z on
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But 99, now we're actually going to clinical trials. Perhaps someone from SleepGuide will actually get to participate.
99 said:this info was first released in 2008
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Permalink Reply by Banyon on
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The description of when the signal is transmitted and how the nerve and muscle responds is unclear and incomplete. Initially Apnex Medical's literature said the system sends a signal when it detects a collapsing airway. This did not seem acceptable to me because I don't want any airway collapses - they should all be prevented.
In the linked document Apnex now says, "During each breath, the system delivers a signal to the hypoglossal nerve using the stimulation lead". "Each breath" sounds better to me because it may be able to prevent all airway collapses.
Now I have a lack of understanding about the exact timing of the stimulation and muscle contraction. Is this a short signal which is followed by a muscle contraction and then subsequently, in the absence of the signal, an inevitable relaxing of the muscle? If so, would a continuous signal work better to keep the muscle constantly contracted?
I am glad to see Dr. Park involved with this product. Apnex Medical took a very wise move to involve him.
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Permalink Reply by Steven Y. Park, MD on
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Banyon,
You're right...the wording is confusing. Sensors in the ribcage detect the onset of an inspiration which quickly triggers stimulation of the nerve that goes to the tongue, BEFORE the onset of obstruction. It's kept on continuously when you're sleeping.
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Permalink Reply by RockRpsgt on
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It is the "stimulation while sleeping" part that I have trouble with. Wouldn't this cause EEG stimulation as well? Do you need any techs Dr. Park? I would love to be a part of this one.
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Steven Y. Park, MD said:Banyon,
You're right...the wording is confusing. Sensors in the ribcage detect the onset of an inspiration which quickly triggers stimulation of the nerve that goes to the tongue, BEFORE the onset of obstruction. It's kept on continuously when you're sleeping.
Thanks.
So if the device is firing a signal at the beginning of an inspiration, does the tongue muscle begin to relax before the beginning of the next inspiration? I am sure this has all been allowed for, but on the surface it sounds like a constant contraction and relaxing of the tongue muscles. When the device originally was publicized, I expected a continuous low-grade signal to the nerve would be required, but then my knowledge of neurology is slight.
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Yes, to a degree. It's a complex algorithm that gently tenses the tongue during inspiration.
Banyon said:Steven Y. Park, MD said:Banyon,
You're right...the wording is confusing. Sensors in the ribcage detect the onset of an inspiration which quickly triggers stimulation of the nerve that goes to the tongue, BEFORE the onset of obstruction. It's kept on continuously when you're sleeping.
Thanks.
So if the device is firing a signal at the beginning of an inspiration, does the tongue muscle begin to relax before the beginning of the next inspiration? I am sure this has all been allowed for, but on the surface it sounds like a constant contraction and relaxing of the tongue muscles. When the device originally was publicized, I expected a continuous low-grade signal to the nerve would be required, but then my knowledge of neurology is slight.
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Rock,
You would think so, but in practice so far, patients tolerate it pretty well. This applies to all three companies that are testing similar devices.
Rock Hinkle said:It is the "stimulation while sleeping" part that I have trouble with. Wouldn't this cause EEG stimulation as well? Do you need any techs Dr. Park? I would love to be a part of this one.
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Permalink Reply by Howkim on
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You ought to have the IRB identifying information and approval number or date on your information. Is this trial registered on clinicaltrials.gov? It's required to be under FDAAA, but the registration does not have to be made public until approval of the device by FDA.
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How many pts have been tested so far Dr. Park?
Steven Y. Park, MD said:Rock,
You would think so, but in practice so far, patients tolerate it pretty well. This applies to all three companies that are testing similar devices.
Rock Hinkle said:It is the "stimulation while sleeping" part that I have trouble with. Wouldn't this cause EEG stimulation as well? Do you need any techs Dr. Park? I would love to be a part of this one.
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Permalink Reply by Rock Conner RRT on
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I'm encouraged by this, having seen good outcomes with similar technology used for diaphragmatic pacing in spinal cord injury patients.
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