| The limitations of traditional methods |
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 visit3. |
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The clinical benefits of Somnoplasty® |
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• Minimally invasive
• Minimal post-operative discomfort
• Safe
• Effective
• Office-based procedure |
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| 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. |
| 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 rates10. |
| Better breathing |
| In recent studies, chronic nasal obstruction patients experienced: |
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• 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 |
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Nasal obstruction assessment before
and after surgery by patient and examiner |
|
Degree of
obstruction |
Frequency of
obstruction |
Nasal
examination |
Parameter
|
Before
|
After
|
Before
|
After
|
Before
|
After
|
Mean
SD
Range
Total score*
Improvement (%) |
6.33
1.64
2–10
272 |
2.63
2.05
0–8
113
58.8 |
6.58
1.95
2–10
283 |
2.86
2.14
0–10
123
56.5 |
2.68
0.96
1–4
118 |
0.41
0.76
0–3
18
84.8 |
*Summation of the scores in VAS (43 nostrils).
SOURCE: Li KK, Riley RW, Powell NB, Troell RJ. Radiofrequency tissue volume reduction for turbinate hypertrophy. Otolaryngol Head Neck Surg. 1998;119(6):569–573. |
| 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%6. |
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Sounder sleep |
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Patients seeking treatment for sleep-disordered breathing (SDB) were treated with Somnoplasty,6 demonstrating: |
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• Decreased daytime sleepiness – as determined by Epworth sleepiness scores
• No infections
• No airway compromises
• Limited, short-term postoperative pain
• Decreased snoring – 77% |
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| 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.1 |
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Rest relief |
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In a recent multicenter study,13 Somnoplasty treatments were shown to: |
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• 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% |
|
Patients and spouses express satisfaction with
the Somnoplasty Procedure |
|
Mean |
| Perception of procedure: |
8.4 |
| 0 (very difficult) – 10 (very easy) |
|
| Spouse’s assessment of improvement: |
7.1 |
| 0 (none) – 10 (greatly improved) |
|
| Patient’s quality of sleep—pre treatment: |
3.6 |
| 1 (very poor) – 10 (very good) |
|
| Patient’s quality of sleep—post treatment: |
7.6 |
| 1 (very poor) – 10 (very good) |
|
| Number of treatments |
1.7 |
| SOURCE: Clarke ME. Clinical experience using radiofrequency tissue volume reduction (RFTVR), Somnoplasty® for the treatment of snoring. Paper presented at the February 1999 meeting of The American College of Oral and Maxillofacial Surgeons, February 24–26, 1999, Orlando, Fla. |
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| 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. |
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