New Minimally Invasive Sleep Apnea Procedure Available
 
Dr. Park is pleased to offer this new, minimally invasive procedure for patients with obstructive sleep apnea. By modifying a standard surgical technique for tongue collapse, this procedure promotes less pain and discomfort and faster healing and recovery. After preliminary testing, it was recently approved by the New York Eye & Ear Infirmary’s Institutional Review Board.
 
WHY IS THIS STUDY BEING DONE?
 
The purpose of this study is to look at the effectiveness of specially designed sutures for tongue collapse in people with obstructive sleep apnea. To date, for people who cannot tolerate CPAP as a form of therapy for obstructive sleep apnea, the only two other options include dental devices and surgery. Dental devices (mandibular advancement devices) pull the tongue forward at night by pulling the lower jaw forward while one sleeps. This works for some people, but not  for everyone. Tongue collapse is a common feature in obstructive sleep. It can exist by itself, or alongside other areas of obstruction, such as at the palatal or the nose. This procedure may be performed in conjunction with a uvulopalatopharyngoplasty operation, or any nasal surgery as well. Our aim is to show that this procedure’s effectiveness is equivalent to the other more invasive and uncomfortable procedures
 
One of the more commonly accepted ways of surgically treating tongue collapse is called a mandibular osteotomy and advancement procedure (MOGA). This involves cutting a rectangular window of bone on your lower jaw in the midline, and the entire block of bone is pulled forward, pulling on the muscle attached behind this bone, called the genioglossus muscle (which attaches to the tongue). Though few, potential complications include jaw bone fracture, tooth injury and numbness, lip numbness or weakness, persistent obstructive sleep apnea, or any anesthesia, allergic or airway complications.
 
Another less invasive, variation of MOGA involves attaching a permanent suture to the back of the lower jaw and looping it around the back of the tongue (Repose suture). This suspends the back of the tongue to the lower jaw so it doesn't fall back. Potential complications include infection, bleeding, tongue numbness or weakness.
 
The hyoid suspension procedure is usually performed in addition to one of the tongue procedures to increase success rates. One study revealed that the hyoid procedure alone lowered the apnea hypopnea index by 50%. This procedure must be performed through a neck incision.
 
The purpose of this study is to apply a minimally invasive way of performing the MOGA and hyoid suspension procedures, but with much less potential for complications and with faster healing than the standard procedures. With this new procedure, it starts the same way as in a MOGA (using an incision behind the lower lip), but a much smaller hole is drilled into the lower midline of your jaw so a thin needle can be passed. This needle is designed to hold at the tip a specially designed suture with knots that hold small dissolvable cones. This suture has been used successfully in facial plastic surgery procedures (minimally invasive facelifts) over 1000 times with a good safety profile.
 
Once the suture is passed into tissue, when pulled back in the opposite direction, the cones hold onto the tissue, preventing it from pulling out (see Figure). A special technique is used to hold the sutures in place.The cones dissolve slowly over months, but the suture remains permanently since healing causes tissue ingrowth around the knots, eventually leading to further scarring and enhanced tissue holding strength.           
 
This suture is passed through the small hole in the jaw and passed into the tongue tissues in three different areas of the tongue and two towards the hyoid bone. All five sutures are pulled gently and tied securely to a small screw or plate on the front of the jaw. The forces that are created simulate the MOGA procedure (pulling on the genioglossus muscle), as well as to simulate the hyoid suspension procedure (pulling the hyoid bone forward). A neck incision is not necessary.
 
The surgery itself is not considered new or experimental. However, the standard technique has been modified to incorporate lesser invasive methods using this special suture. It also eliminates the need for a neck incision when performing the hyoid procedure. We expect similar results compared with standard procedures.
 
HOW MANY PEOPLE WILL TAKE PART IN THIS STUDY?
 
Five patients will be enrolled in a pilot study. Another 20 patients may be enrolled after the initial pilot stage, for improved statistical analysis.
 
WHO CAN PARTICIPATE IN THE STUDY?
 
Potential candidates must be personally examined by Dr. Park for formal consultation. Patients must have undergone a formal overnight polysomnogram with documented obstructive sleep apnea (AHI > 5) within the past 2 years with no significant change in their weight or symptoms. They must have tried or refused all available nonsurgical options (CPAP or mandibular advancement devices), and must be ideal candidates for traditional upper airway surgery. Patients that are not candidates for the procedure will receive a comprehensive evaluation with recommendations for other nonsurgical options. Potential candidates may also elect to undergo traditional sleep apnea surgery instead.
 
Entry criteria include the following: 
 
    • men and women ages 18 to 65
    • supine Park tongue position 3+ or greater
    • Friedman Stage II/III
    • BMI < 30
        • AHI  > 5
        • must be medical stable to undergo general anesthesia.
 
Exclusion criteria:
 
    • prior throat surgery
    • history of radiation to the head and neck
    • dysmorphic facies or craniofacial syndromes
    • ASA class IV or V
    • major depression or unstable psychiatric disorder
    • pregnancy
    • illiteracy (unable to complete required forms)
    • no phone # or mailing address, or plans to change in 3           
            month period
        • any upper airway surgery within three month period
 
WHAT IS INVOLVED IN THE STUDY?
 
All patients who participate in the study will be asked to complete a total of 3 surveys. You will complete one less than 2 weeks before you undergo the procedure, three months and one year after your procedure. Each survey will take about 20-30 minutes to complete.
 
The procedure can take anywhere from 2-3 hours, under general anesthesia. For the routine procedures, most patients stay in the hospital 2-4 days and go home after they can swallow enough soft foods to prevent from becoming dehydrated. It is expected that with the new procedure, you will swallow faster and go home faster, within 1-2 days.
 
HOW LONG WILL I BE IN THE STUDY?
 
Patients will be in the study for one year after your procedure. Participation ends after the third questionnaire and and a post-operative sleep study at the one year mark.
 
WHAT ARE THE RISKS OF THE STUDY?
 
Possible complications include infection, bleeding, foreign body reaction, dental numbness or pain, jaw fracture, lip numbness, tongue weakness or numbness, or any anesthetic, allergic or airway complications. Similar type studies have reported about a 70-80% success rate. We expect similar success rates with this new procedure. The potential complications from the uvulopalatopharyngoplasty procedure include leakage of air or fluid into your nose when swallowing, infection, bleeding, a lump sensation, or any anesthetic, airway, or allergic complications. Any necessary palatal procedures will be performed using a Coblator wand, which is found to diminish pain significantly compared with standard techniques. Risk of serious complications are less than 1-2%.
 
There is a small possibility that even if initially successful, the sutures may pull through slowly over time. This is not expected to occur, as there will be scarring and tissue ingrowth into the suture knots. A sleep study is performed one year after the procedure to confirm this.
 
In the small chance that the procedure is not technically achievable, the standard Repose suture and hyoid suspension through a neck incision will be offered instead.
 
If there is a need for removal of the sutures (due to infection, foreign body reaction, etc), it can be removed at any time, but must be preformed in the operating room under general anesthesia.
 
ARE THERE BENEFITS TO TAKING PART IN THE STUDY?
 
The purpose of surgery is to eliminate the need for CPAP. We estimate that about 80% of people who undergo this procedure will have a significant drop in the rate of breathing pauses at night due to obstruction (the apnea hypopnea index). By lowering the apnea hypopnea index, most patients wake up much more refreshed and have more energy during the day. It will also lower your risk factors for heart disease in the future.
 
WHAT ARE THE COSTS?
 
There will be no additional costs to you as a result of being in the study, except for the costs associated with routine surgery appropriate for this condition. This is routine sleep apnea surgery, with only a minor technical modification. Therefore, the charge for services rendered for your condition (care you would have received whether or not you were in this study) will be charged to you or your insurance company. You may wish to contact your insurance company to discuss this further.
 
WHAT ABOUT COMPENSATION?
 
There is no compensation for participating in this study. 
 
WHERE CAN I FIND OUT MORE INFORMATION?
 
Call Dr. Steven Y. Park at 212-315-9058, or email him at sypark@mac.com.