Sleep Apnea Implant - Clinical Study / CPAP Alternative
-
- Posts: 10
- Joined: Tue Aug 25, 2015 5:24 pm
Sleep Apnea Implant - Clinical Study / CPAP Alternative
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.
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.
Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative
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.
- chunkyfrog
- Posts: 34378
- Joined: Mon Jul 12, 2010 5:10 pm
- Location: Nebraska--I am sworn to keep the secret of this paradise.
Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative
Me, likewise, but I can think of several people--some here.
Your biggest obstacle will be affordability/insurance participation.
Your biggest obstacle will be affordability/insurance participation.
_________________
Mask: AirFit™ P10 For Her Nasal Pillow CPAP Mask with Headgear |
Additional Comments: Airsense 10 Autoset for Her |
Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative
Similar to the Inspire implant? I looked into that, but my BMI was too high.
_________________
Machine: PR System One REMStar 60 Series Auto CPAP Machine |
Mask: Simplus Full Face CPAP Mask with Headgear |
Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative
According to this site, there aren't any charges.chunkyfrog wrote:Me, likewise, but I can think of several people--some here.
Your biggest obstacle will be affordability/insurance participation.
http://thnstudy.com/about-the-study/
Asked for a callback to find out more information.
49er
_________________
Mask: SleepWeaver Elan™ Soft Cloth Nasal CPAP Mask - Starter Kit |
Humidifier: S9™ Series H5i™ Heated Humidifier with Climate Control |
Additional Comments: Use SleepyHead |
- chunkyfrog
- Posts: 34378
- Joined: Mon Jul 12, 2010 5:10 pm
- Location: Nebraska--I am sworn to keep the secret of this paradise.
Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative
. . . I meant if/when it gets to the marketplace.
_________________
Mask: AirFit™ P10 For Her Nasal Pillow CPAP Mask with Headgear |
Additional Comments: Airsense 10 Autoset for Her |
Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative
Sorry about that.chunkyfrog wrote:. . . I meant if/when it gets to the marketplace.
_________________
Mask: SleepWeaver Elan™ Soft Cloth Nasal CPAP Mask - Starter Kit |
Humidifier: S9™ Series H5i™ Heated Humidifier with Climate Control |
Additional Comments: Use SleepyHead |
- chunkyfrog
- Posts: 34378
- Joined: Mon Jul 12, 2010 5:10 pm
- Location: Nebraska--I am sworn to keep the secret of this paradise.
Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative
No problem. I was not as clear as I intended.
Sometimes my brevity is born out of laziness.
Sometimes my brevity is born out of laziness.
_________________
Mask: AirFit™ P10 For Her Nasal Pillow CPAP Mask with Headgear |
Additional Comments: Airsense 10 Autoset for Her |
Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative
I seriously doubt you are lazy.chunkyfrog wrote:No problem. I was not as clear as I intended.
Sometimes my brevity is born out of laziness.
_________________
Mask: SleepWeaver Elan™ Soft Cloth Nasal CPAP Mask - Starter Kit |
Humidifier: S9™ Series H5i™ Heated Humidifier with Climate Control |
Additional Comments: Use SleepyHead |
-
- Posts: 10
- Joined: Tue Aug 25, 2015 5:24 pm
Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative
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.
And because it's a clinical study, the system, surgery, medical visits and clinical support is free for participants.
Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative
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.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.
49er
_________________
Mask: SleepWeaver Elan™ Soft Cloth Nasal CPAP Mask - Starter Kit |
Humidifier: S9™ Series H5i™ Heated Humidifier with Climate Control |
Additional Comments: Use SleepyHead |
-
- Posts: 10
- Joined: Tue Aug 25, 2015 5:24 pm
Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative
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
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
Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative
Thanks Sleeping Paul for clarifying things.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
49er
_________________
Mask: SleepWeaver Elan™ Soft Cloth Nasal CPAP Mask - Starter Kit |
Humidifier: S9™ Series H5i™ Heated Humidifier with Climate Control |
Additional Comments: Use SleepyHead |
Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative
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?
Re: Sleep Apnea Implant - Clinical Study / CPAP Alternative
"Your" centre? This forum's about Cpap - it's not a medical or research centre... unless that was directed at someone or something else?
_________________
Mask: Ultra Mirage™ Full Face CPAP Mask with Headgear |
Humidifier: IntelliPAP Integrated Heated Humidifier |
Last edited by Julie on Tue Sep 01, 2015 7:26 pm, edited 1 time in total.