New Surgigal Procedure For OSA

I rarely post on the forum because of my inexperience with CPAP. However, I thought I would pass along the following information on a new surgical procedure for OSA. It is an implantable medical device that is in clinical trials(Apex Clinical Research Study). Below is the information I received this week from my ENT who is involved in the clinical trials. Addtional information is available at apexmedical.com.



Apnex Clinical Research Study

Investigational Implantable Device for Obstructive Sleep Apnea
Apnex Medical has developed an implantable device for people with obstructive sleep apnea.
This investigational treatment is being evaluated in a clinical research study to determine if it is
safe and effective in treating this condition. This brochure contains background information on
the following topics: obstructive sleep apnea, the Apnex therapy option and the clinical study.

The Apnex Hypoglossal Nerve Stimulation (HGNS™) System is an implantable medical device that is
being investigated in a clinical research study for the treatment of obstructive sleep apnea. It includes
the following components:

The Apnex Therapy
The system is programmed to
automatically deliver therapy according
to a patient’s sleep schedule. When
the patient falls asleep, the system
monitors breathing using the respiration
sensing leads. During each breath,
the system delivers a signal to the
hypoglossal nerve using the stimulation
lead. The hypoglossal nerve activates
the genioglossus muscle, which helps
keep the airway open during sleep.

A description of how the system works is
shown in Figure 2. The therapy stops
according to the patient’s programmed
sleep schedule. Patients also have the
option to use the therapy controller to
stop and start therapy to meet their
sleep needs.

How It Works
The surgery associated with implanting the Apnex HGNS System is estimated to take about one to three hours.
Patients may go home the same day as the surgery or they may stay overnight in the hospital. Patients can resume
normal daily living activities soon after surgery. After a one month healing period, the system is programmed by a
doctor during a sleep study to meet the unique needs of the patient.

Surgical and Programming Procedures
• Apnex Implantable Neurostimulator (INS device):
implanted below the collarbone
• Apnex Respiration Sensing Leads (RSLs): implanted
under the skin and placed along the lower edge of the
ribs and connected to the neurostimulator
• Apnex Stimulation Lead (STL): implanted under the
skin and placed around the hypoglossal nerve in the
neck region and connected to the neurostimulator
• Apnex Therapy Controller: can be used by
patients to start or stop therapy to meet their
sleep needs
• Apnex Programmer System: an external
device used by doctors to non-invasively
program the therapy settings

Figure 2.
The hypoglossal nerve
activates the genioglossus
muscle, which helps keep the
airway open during sleep.

During each breath, the
system delivers a signal
to the hypoglossal nerve
using the stimulation lead.

The system is programmed
to automatically deliver
therapy according to the
patient’s sleep schedule.

When the patient falls
asleep, the system monitors
breathing using the respiration
sensing leads.

Therapy stops
according to the
patient’s programmed
schedule. The patient
can also use the
therapy controller
to stop therapy.

Apnex Clinical Research Study

The goals of the study are to determine if the
Apnex HGNS System will be safe and effective
in people with moderate-to-severe obstructive
sleep apnea. The Apnex HGNS System is
anticipated to reduce the number of sleep
apnea events and related symptoms, such as
daytime sleepiness. If it is successful in treating
obstructive sleep apnea, it has the potential to
prevent or reverse the serious health effects
and risks of this condition.

Clinical Study Goals
A person will be considered for study participation
if they meet the following key requirements:
• Moderate-to-severe obstructive sleep apnea
• Failed or does not tolerate CPAP therapy
• 21 to 70 years of age
• Body mass index (BMI) < 37 kg/m2
The clinical study doctor will provide information on
additional requirements to determine if an individual
qualifies for the study.

Participant Eligibility
All patients will be implanted with the Apnex
HGNS System. The device will be turned on one
month after the implant procedure and a sleep
study will be done to adjust therapy delivery.
Additional follow-up visits will occur at 2, 3, 6, 12,
24 and 36 months.

Clinical Study Plan
All patients who enroll in the study are expected
to adhere to the following guidelines:
• Patients must keep all follow-up appointments
with the study doctor and sleep clinic at the
scheduled times
• Patients should notify the study doctor of any
changes in their condition, any new medications
or medical treatments that may be considered
for other health conditions

Participant Requirements
If this therapy is effective in treating obstructive
sleep apnea, it could reduce its symptoms, such
as daytime sleepiness and potentially prevent or
reverse the serious health effects and risks of this
condition.
The Apnex Therapy is anticipated to be easy to
use and would allow a person to sleep naturally,
without the use of CPAP or other equipment.
It involves surgery that does not permanently
remove or alter tissue, leaving open alternative
treatment options.
It is possible that a participant’s condition
will not change with this treatment. Even if a
participant does not experience an immediate
benefit from this treatment, others may benefit
from information obtained in the clinical study.

Potential Benefits of Participation
The surgical risks associated with the Apnex
HGNS System will be similar to the risks related
to surgical procedures involving the neck, and
implantation of a neurostimulator system. Study
participants may be exposed to risks associated
with the long-term use of the Apnex HGNS
System. Other risks may exist that are not known
at this time.

Patients that agree to participate in the study
will sign an informed consent document after
their doctor reviews with them all known risks
associated with the treatment. Study participants
will be monitored by their doctors on a regular
basis to limit risks.

Potential Risks of Participation
Release 3
© Copyright 2008 Apnex Medical, Inc. All Rights Reserved.
Potential advances in technology require rigorous testing to determine their value. Involvement in
this study will help determine if this treatment is safe and effective for millions of people who suffer from
moderate-to-severe obstructive sleep apnea.
Individuals should be fully informed and be able to determine to the best of their ability whether enrolling
in this clinical research study is right for them. Making that decision is not an easy task. Study doctors will
respect any decision that is made.
Your consideration to be involved in this clinical research study reflects your effort to do as much as
possible to treat your obstructive sleep apnea condition and reduce the serious health risks associated
with it. The trade-off involved in your decision is evaluating an investigational treatment that has the
potential to effectively treat your condition versus the unknown outcomes associated with this treatment.
Taking the Next Step
1. Access Economics Pty Limited Report for Sleep Health Australia, Wake Up Australia: The Value of Healthy Sleep (2004).
2. Lindberg E, Carter N, Gislason T, Janson C. Role of snoring and daytime sleepiness in occupational accidents.
Am J Respir Crit Care Med 2001;164:2031-2035.
3. Akashiba T, Kawahara S, Akahoshi T, et al. Relationship between quality of life and mood or depression in patients with
severe obstructive sleep apnea syndrome. Chest 2002;122:861-865.
4. Mulgrew AT, Nasvadi G, Butt A, et al. Risk and severity of motor vehicle crashes in patients with obstructive sleep apnoea/
hypopnoea. Thorax 2008;63:536-541.
5. Lindberg E, Carter N, Gislason T, Janson C. Role of snoring and daytime sleepiness in occupational accidents.
Am J Respir Crit Care Med 2001;164:2031-5.
6. Shahar E, Whitney CW, Redline S, et al. Sleep-disordered breathing and cardiovascular disease: cross-sectional results of the
Sleep Heart Health Study. Am J Respir Crit Care Med 2001;163:19-25.
7. Yaggi HK, Concato J, Kernan WN, et al. Obstructive sleep apnea as a risk factor for stroke and death.
N Engl J Med 2005;353:2034-2041.
8. Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and
hypertension. N Engl J Med 2000;342:1378-1384.
9. Reichmuth KJ, Austin D, Skatrud JB, Young T. Association of sleep apnea and type II diabetes: a population-based study.
Am J Respir Crit Care Med 2005;172:1590-1595.
10. Young T, Finn L, Peppard PE, Szklo-Coxe M, et al. Sleep disordered breathing and mortality: eighteen-year follow-up of
the Wisconsin Sleep Cohort. SLEEP 2008;31:1071-1078.
References
Apnex Medical™, Inc.
2890 Centre Pointe Drive
St. Paul, MN 55113 USA
+1.651.757.4300
info@apnexmedical.com
http://www.ApnexMedical.com
For Further Information Contact
CAUTION: Exclusively for Clinical Investigators and Study Participants.
CAUTION: Investigational Device Limited by Federal Law to Investigational Use.
FOR CLINICAL TRIAL USE ONLY.

It is not so new: Feb 27, 2009 - viewtopic.php?f=1&t=39245&p=343232&hili ... re#p343232

Several long threads in the forum already.