How are obstructive sleep apnoea
patients treated now?

How is Somnoplasty used to treat
obstructive sleep apnoea?

What does the patient experience
during the Somnoplasty procedure?

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

Who can be treated?

How are obstructive sleep apnoea patients treated now?

Traditional therapy for obstructive sleep apnoea 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 apnoea and related symptoms.

Surgical methods for treating obstructive sleep apnoea 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.

Laser palatoplasty (LAUP) is also an effective treatment for palatal snorers. Patients have differing areas of aorway obstruction and will require differing treatment on a c ase by case basis.

Other surgical methods for treating obstructive sleep apnoea 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 apnoea, when other interventions are either ineffective or unacceptable. These treatments are invasive and expensive, may require general anaesthesia and hospitalisation, and result in a lengthy, painful recovery period.

How is Somnoplasty used to treat obstructive sleep apnoea?

The Somnoplasty procedure for obstructive sleep apnoea, which is performed under local anaesthesia, treats sleep apnoea 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 anaesthesia. The System includes an automated RF generator with temperature monitoring capabilities and a suite of proprietary, single-use, dispobstructive sleep apnoeable surgical handpieces that deliver controlled thermal energy into targeted areas to reduce tissue volume and stiffen soft tissue. The Somnoplasty procedure for obstructive sleep apnoea generates heat at approximately 85°C 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 apnoea 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 apnoea is performed under local anaesthesia 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 apnoea, 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 apnoea?

Tongue Based Obstruction
Initial clinical results showed that the Somnoplasty System effectively treated obstructive sleep apnoea 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. However, jaw splints are the current effective method for treatment of tongue base obstruction via telescopic examination of the throat.

Who can be treated?

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

The Somnoplasty System has been cleared by the FDA in the USA for use in the treatment of two conditions: habitual snoring (uvula and soft palate) and chronic nasal obstruction (enlarged inferior turbinates). As of October 1998, more than 3,000 patients have been treated with the Somnoplasty System.