Sleep Apnea Implant - Clinical Study / CPAP Alternative

General Discussion on any topic relating to CPAP and/or Sleep Apnea.
sleepingpaul
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Sleep Apnea Implant - Clinical Study / CPAP Alternative

Post by sleepingpaul » Tue Aug 25, 2015 5:39 pm

Hi guys, I'm new to this forum and noticed several conversation threads about CPAP alternatives.

I thought you might be interested in finding out more about another sleep apnea implant (not Inspire) that is currently being evaluated by the FDA in a clinical study in the US. I am an executive at the company sponsoring the study, and Doctors are now recruiting and enrolling patients for the study in 12 sites across the US.

The treatment is called THN Sleep Therapy. It consists of a fully implantable device that treats Obstructive Sleep Apnea (OSA) by delivering muscle tone to key tongue muscles, effectively controlling upper airway flow and significantly reducing or eliminating sleep apnea.

This study is only recommended for moderate and severe OSA patients who are unable or unwilling to use PAP therapy. The study is not suited for those of you who are happy with CPAP therapy.

To find out more about the therapy and the study, please visit thnstudy.com.

Corky1121
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Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative

Post by Corky1121 » Tue Aug 25, 2015 5:56 pm

No thanks. I don't want any implants in my body.
Diagnosed after home study with 37 obstructive Apneas. Indexed at 22 Per hour. Moderate Apnea. Have suffered migraines and waking up stiff and tired and at times with muscle spasms.

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chunkyfrog
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Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative

Post by chunkyfrog » Tue Aug 25, 2015 8:01 pm

Me, likewise, but I can think of several people--some here.
Your biggest obstacle will be affordability/insurance participation.

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alpha752
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Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative

Post by alpha752 » Tue Aug 25, 2015 8:06 pm

Similar to the Inspire implant? I looked into that, but my BMI was too high.

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49er
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Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative

Post by 49er » Tue Aug 25, 2015 8:34 pm

chunkyfrog wrote:Me, likewise, but I can think of several people--some here.
Your biggest obstacle will be affordability/insurance participation.
According to this site, there aren't any charges.

http://thnstudy.com/about-the-study/

Asked for a callback to find out more information.

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chunkyfrog
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Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative

Post by chunkyfrog » Tue Aug 25, 2015 8:56 pm

. . . I meant if/when it gets to the marketplace.

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49er
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Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative

Post by 49er » Tue Aug 25, 2015 8:58 pm

chunkyfrog wrote:. . . I meant if/when it gets to the marketplace.
Sorry about that.

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chunkyfrog
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Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative

Post by chunkyfrog » Tue Aug 25, 2015 9:02 pm

No problem. I was not as clear as I intended.
Sometimes my brevity is born out of laziness.

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49er
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Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative

Post by 49er » Tue Aug 25, 2015 10:07 pm

chunkyfrog wrote:No problem. I was not as clear as I intended.
Sometimes my brevity is born out of laziness.
I seriously doubt you are lazy.

sleepingpaul
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Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative

Post by sleepingpaul » Wed Aug 26, 2015 12:02 pm

Not sure this will help you, but while the BMI limit for the Inspire system is 32, THN Sleep Therapy's limit is higher at 35.

And because it's a clinical study, the system, surgery, medical visits and clinical support is free for participants.

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49er
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Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative

Post by 49er » Wed Aug 26, 2015 12:15 pm

sleepingpaul wrote:Not sure this will help you, but while the BMI limit for the Inspire system is 32, THN Sleep Therapy's limit is higher at 35.

And because it's a clinical study, the system, surgery, medical visits and clinical support is free for participants.
Thanks sleepingpaul, my BMI is normal so this isn't something I have to worry about. But as an FYI, in the podcast by Dr. Park on cpap alternatives that CG posted a link to, he said the procedure works better for people who are thin. Obviously, that is just one person's opinion but I wanted to mention that. I haven't seen supporting evidence either way on this issue.

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sleepingpaul
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Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative

Post by sleepingpaul » Wed Aug 26, 2015 12:40 pm

49er, thanks for your comment - I will clarify a couple things.

Dr. Park was involved in a previous study (another sponsor) for a system that had limited reach in terms of patient inclusion criteria - and it was mainly because all the system did was "push" the tip of the tongue forward. In high BMIs, that "push" needs to be very considerable to open up the airway, a tough task, hence the limitation to "thin people" (low BMIs).

In THN Sleep Therapy's case, it is not trying to "push" the tongue out, but it's only delivering and maintaining "muscle tone" to key tongue muscles (preventing the tongue from relaxing and blocking the airway). It's basically trying to maintain the same muscle tone you'd have when you are awake.

By the way, the system is already approved and for sale in Europe. Other US patients (that participated in the sponsor's previous study) can be seen in a video here, and I'd consider their weight to be the average for OSA patients: http://imtheramedical.com/patients/

But I understand the concern from Physicians overall until data proves otherwise... and that's what we're working on

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49er
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Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative

Post by 49er » Wed Aug 26, 2015 1:54 pm

sleepingpaul wrote:49er, thanks for your comment - I will clarify a couple things.

Dr. Park was involved in a previous study (another sponsor) for a system that had limited reach in terms of patient inclusion criteria - and it was mainly because all the system did was "push" the tip of the tongue forward. In high BMIs, that "push" needs to be very considerable to open up the airway, a tough task, hence the limitation to "thin people" (low BMIs).

In THN Sleep Therapy's case, it is not trying to "push" the tongue out, but it's only delivering and maintaining "muscle tone" to key tongue muscles (preventing the tongue from relaxing and blocking the airway). It's basically trying to maintain the same muscle tone you'd have when you are awake.

By the way, the system is already approved and for sale in Europe. Other US patients (that participated in the sponsor's previous study) can be seen in a video here, and I'd consider their weight to be the average for OSA patients: http://imtheramedical.com/patients/

But I understand the concern from Physicians overall until data proves otherwise... and that's what we're working on
Thanks Sleeping Paul for clarifying things.

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desperateforsleep2

Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative

Post by desperateforsleep2 » Tue Sep 01, 2015 4:28 pm

I saw the animation video about the therapy and Im interested in finding out more... I went through the questionnaire but there's nothing going on in Miami. Is there a way of flying to your center if I'm not in the same city?

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Julie
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Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative

Post by Julie » Tue Sep 01, 2015 4:56 pm

"Your" centre? This forum's about Cpap - it's not a medical or research centre... unless that was directed at someone or something else?
Last edited by Julie on Tue Sep 01, 2015 7:26 pm, edited 1 time in total.