Somnoplasty for Obstructive Sleep Apnea

Clinical Overview

For years, the medical community has searched for a less invasive solution for the treatment of upper-airway disorders. Surgical therapies have succeeded in reducing obstructions in some patients, but carry significant risks and almost always result in significant postoperative pain. Nonsurgical methods have offered patients some relief, but often prove ineffective because of variable compliance and widespread patient discomfort.

Patients with chronic nasal obstruction from enlarged turbinates often endure the prolonged use of intranasal sprays and systemic medications. Some carry significant side effects – and compliance over time can be inconsistent. The morbidity associated with surgical procedures includes pain, bleeding, the need for nasal packing, adhesion, crusting, dryness and infection.

Those who suffer from obstructive sleep apnea have often been treated with continuous positive-airway pressure (CPAP). CPAP has a disturbingly low compliance rate (25% to 50%) and is only a palliative treatment. Uvulopalatoplasty (UPPP) procedures can be extremely painful, and variably effective. In more extreme cases, patients have been subjected to genioglossal advancement and tracheotomies.

Many patients who seek treatment for habitual snoring have most recently experienced the discomfort of the laser-assisted uvulopalatoplasty (LAUP) – a multiphase procedure so invasive and painful that it can discourage patients from returning after their first visit.

The clinical benefits of Somnoplasty®

Minimally invasive
Minimal post-operative discomfort
Safe
Effective
Office-based procedure

A simple solution

Somnoplasty, from Gyrus ENT, is an office-based procedure performed using local anesthesia to treat upper-airway obstructions. Somnoplasty uses controlled, low-power radiofrequency energy to create one or several submucosal volumetric lesions. Over a period of 6 to 8 weeks, the lesions are naturally resorbed, reducing tissue volume and stiffening remaining tissue in the desired area.

Alleviating obstructive sleep apnea syndrome

Somnoplasty is an effective and minimally invasive choice for the treatment of obstructive sleep apnea syndrome. Delivering radiofrequency energy submucosally to the base of tongue, Somnoplasty creates limited zones of coagulation beneath the tissue surface. As lesions resorb, they stiffen and reduce the tissue in the base of tongue. A study published for OSAS/UARS reported a 55% reduction in the mean respiratory disturbance index (RDI) from baseline for all subjects – with an overall mean reduction in tongue volume of 17%.

Sounder sleep

Patients seeking treatment for sleep-disordered breathing (SDB) were treated with Somnoplasty,6 demonstrating:

Decreased daytime sleepiness – as determined by Epworth sleepiness scores
No infections
No airway compromises
Limited, short-term postoperative pain
Decreased snoring – 77%

Quieting habitual snoring

It is estimated that over 40 million North Americans are affected by habitual snoring – often resulting from the narrowing and partial obstruction of the upper airway due to abnormal size and positioning of the soft palate and uvula.11-12 Somnoplasty provides a relatively painless procedure to treat habitual snoring – reducing soft-palate tissue volume in a precise minimally invasive manner.4,8 Snoring has been shown to decrease following tissue – volume reduction,1,5 and recent studies have shown post-treatment pain to range from negligible to mild.

Rest relief

In a recent multicenter study,13 Somnoplasty treatments were shown to:

Deliver a 85.3% success rate for up to two Somnoplasty treatment sessions
Reduce mean snoring index 60.6%
Reduce mean Epworth Sleepiness Score 37.5%

Somnoplasty – the logical conclusion

Somnoplasty has proven to be an excellent option to relieve upper-airway obstructions with minimum intraoperative and postoperative pain. In a recent study on habitual snoring,14 9% of patients undergoing Somnoplasty needed narcotic analgesics, as compared to 100% of patients undergoing LAUP and UPPP upper-airway procedures. Somnoplasty has also been shown to effectively reduce tongue-tissue volume for the treatment of obstructive sleep apnea. It is a feasible and safe method for palate-tissue reduction for the treatment of habitual snoring. And Somnoplasty has also proven effective in the improvement of nasal obstruction caused by turbinate hypertrophy. With an ever-expanding list of potential clinical applications, the Somnoplasty platform technology promises a future of continued innovation and leadership in the treatment of upper-airway obstructions.

Outpatient Procedure to Correct Obstructive Sleep Apnea

Until now patients with obstructive sleep apnea faced a limited and unpleasant choice of treatments. Somnoplasty ® is a new, minimally invasive, outpatient procedure that reduces and tightens excess tissue responsible for obstructive sleep apnea, including the base of tongue, the most difficult to treat source of obstruction.

Sleep studies have demonstrated that Somnoplasty, through reduction of excess tissue volume, can effectively treat obstructive sleep apnea.

With the Somnoplasty handpieces, the physician creates limited zones of coagulation beneath the surface of the tissue. These lesions are naturally resorbed over time, leading to reduction in tissue volume and resolution of the obstruction. Typically, more than one treatment is necessary to achieve optimal results.

The 30 to 45 minute procedure takes place under local anesthesia with patients typically resuming normal activities the following day.

Reducing chronic nasal obstruction

Chronic enlargement of turbinates affects over 1.5 billion people worldwide and is irreversible except through surgical intervention. Through a partially insulated electrode, Somnoplasty reduces turbinate tissue with minimal, if any, crusting or bleeding. The procedure typically takes less than 2 minutes per turbinate. One study demonstrated that 89% of patients were no longer using medication for nasal obstruction at the end of 8 weeks9 multiple lesions have resulted in improved response rates.

Better breathing

In recent studies, chronic nasal obstruction patients experienced:
Improved breathing in 100% of participants
Decreased degree and frequency of nasal obstruction— 81%
Minimal adverse effects—no bleeding, crusting, dryness, foul odor or need for nasal packing

Frequently Asked Questions

What is obstructive sleep apnea?

Obstructive sleep apnea has a profound impact on an individual's health. Excessive daytime sleepiness caused by disruption of normal sleep patterns leads to a significant increase in the rate of accidents for obstructive sleep apnea patients, including a sevenfold increase in automobile accidents. Over the long term, obstructive sleep apnea is associated with greater risk of hypertension and cardiovascular disease and the National Commission on Sleep Disorders Research estimates that 38,000 cardiovascular deaths due to sleep apnea occur each year.

In addition, loud snoring and intermittent breathing interruptions can affect the quality of sleep of the obstructive sleep apnea patient's bedpartner. Witnessing an apnea can be a frightening experience because the obstructive sleep apnea patient appears to be suffocating. Frequently, it is a sleep-deprived bedpartner who convinces the apneic patient to seek medical help.

What are the health implications of obstructive sleep apnea?

Who suffers from obstructive sleep apnea?

Twenty-four percent of adult men and nine percent of adult women, or more than 20 million Americans, are estimated to have some degree of obstructive sleep apnea. Of these, six million are estimated to have cases severe enough to warrant immediate therapeutic intervention. However, obstructive sleep apnea was not well understood or recognized by primary care physicians until recently, and only a fraction of these 20 million obstructive sleep apnea patients have been diagnosed and treated by a physician. Somnus believes the number of patients currently undergoing treatment to be less than 500,000. With increased awareness in the physician and patient communities, a growing number of new patients are expected to be identified for treatment in the next few years.

While obstructive sleep apnea is commonly associated with obesity and male gender, it affects a broad cross-section of the population. Other risk factors include habitual snoring, which is often a precursor of more serious upper airway disorders such as obstructive sleep apnea. In fact, results from a recent study indicate that one in three men and nearly one in five women who snore habitually suffer from some degree of obstructive sleep apnea.

How are obstructive sleep apnea patients treated now?

Traditional therapy for obstructive sleep apnea includes nightly use of continuous positive airway pressure (CPAP). During sleep, CPAP patients wear a face mask connected to a pump that forces air into the nasal passages at pressures high enough to overcome obstructions in the airway and stimulate normal breathing. CPAP is effective, but many patients find the mask uncomfortable, claustrophobic or embarrassing. CPAP patients often suffer from side effects related to forced air delivery including nasal congestion, sore eyes, headaches and abdominal bloating, and about half of CPAP patients discontinue treatment. Since CPAP is not a cure and must be used every night for life, non-compliant patients experience a full return of obstructive sleep apnea and related symptoms.

Surgical methods for treating obstructive sleep apnea include uvulopalatopharyngeoplasty (UPPP), the surgical resection of the uvula, part of the soft palate, tonsils and possibly other excess tissue in the throat. UPPP is an invasive procedure that typically requires general anesthesia and an overnight hospital stay, and it does not address obstructions at the base of tongue. Other surgical methods for treating obstructive sleep apnea are invasive and involve reducing the size of the tongue through surgical resection, moving the tongue or the jaw forward, or bypassing the obstruction through a tracheostomy. A tracheostomy, or the opening of a collateral airway through the neck, is typically reserved for the most severe cases of obstructive sleep apnea, when other interventions are either ineffective or unacceptable. These treatments are invasive and expensive, may require general anesthesia and hospitalization, and result in a lengthy, painful recovery period.

How does the Somnoplasty System treat obstructive sleep apnea?

Watch the Somnus Turbinoplasty Video

The Somnoplasty procedure for obstructive sleep apnea, which is performed under local anesthesia, treats sleep apnea by shrinking soft tissue in the upper airway including the base of tongue, the source of obstruction that is most difficult to treat. Somnus' proprietary Somnoplasty™ System is designed to use radiofrequency (RF) energy to provide a minimally invasive and less painful treatment of upper airway obstructions under local anesthesia. The System includes an automated RF control unit with temperature monitoring capabilities and a suite of proprietary, single-use, disposable surgical handpieces that deliver controlled thermal energy into targeted areas to reduce tissue volume and stiffen soft tissue.

The Somnoplasty procedure for obstructive sleep apnea generates heat at approximately 85° C (185° F) to create finely controlled coagulative lesions at precise locations within the upper airway. An insulating sleeve at the base of the needle electrode is intended to protect the surface of the tissue from thermal damage, thereby minimizing post-operative discomfort. The lesions created by the procedure are naturally resorbed in approximately three to eight weeks, reducing excess tissue volume and opening the airway. Typically, the Somnoplasty procedure for obstructive sleep apnea takes 30 to 45 minutes, with only five to 10 minutes required for RF energy delivery. The procedure is performed on an outpatient basis and after being monitored overnight, patients can return to their normal activities the following day. Typically, more than one treatment is necessary to achieve optimal results.

What does the patient experience during the Somnoplasty procedure?

The Somnoplasty procedure for obstructive sleep apnea is performed under local anesthesia in an outpatient setting. The protection of the delicate surface of the tissue, the controlled delivery of energy and the ability to maintain a constant, low temperature present a sharp contrast to conventional surgery. Patients undergoing traditional surgery can suffer significant pain and take narcotic medications for several weeks. After the Somnoplasty procedure for obstructive sleep apnea, patients may experience swelling and some discomfort, and take pain medications for two to three days.

How effective is the Somnoplasty System in the treatment of obstructive sleep apnea?

Initial clinical results showed that the Somnoplasty System effectively treated obstructive sleep apnea by shrinking the base of tongue-the most difficult source of obstruction to treat-in moderately and severely affected patients. These results were presented at the Annual Meeting of the American Academy of Otolaryngology-Head and Neck Surgery Foundation in September 1998, with data from 18 patients. Sophisticated testing and analysis following treatment with the Somnoplasty System indicated that patients experienced an average of 17 percent and as much as a 35 percent reduction in tongue tissue volume, a range that is comparable to conventional surgical techniques.

Who is a candidate for the Somnoplasty procedure for obstructive sleep apnea?

All potential candidates should be evaluated by a physician to confirm the presence of obstructive sleep apnea (through an overnight sleep study) and identify the possible sites of airway obstruction.

Is the Somnoplasty procedure for obstructive sleep apnea commercially available throughout the U.S.?

More than 800 doctors in the United States are already performing the Somnoplasty procedure for habitual snoring and chronic nasal obstruction; 300 of these physicians have been trained to perform the Somnoplasty procedure on patients diagnosed with obstructive sleep apnea. Training courses for physicians interested in the obstructive sleep apnea procedure are offered on an ongoing basis and, after attending training, additional physicians will offer the Somnoplasty procedure. For information about commercial availability of the Somnoplasty procedure in your area, contact Somnus' toll-free number: 800-262-3540.Physicians interested in the Somnoplasty procedure should contact Somnus at 800-262-3540

What other conditions can be treated with Somnoplasty?

The Somnoplasty System has already been cleared by the FDA for use in the treatment of three conditions: habitual snoring (soft palate and uvula), chronic nasal obstruction (enlarged inferior turbinates) and OSAS/UARS. As of June 1999, more than 20,000 patients have been treated with Somnoplasty Procedures.

	Clinical Overview
	Outpatient Procedure for Sleep Apnea
	Relief for Chronic Nasal Obstruction
	Frequently Asked Questions
	Make An Appointment

Watch the Somnus Turbinoplasty Video