Release: September 9, 2001

Contact: Kenneth Satterfield(703) 519-1563[email protected]303-228-8460 (9/7-9/12)

A FOLLOW-UP STUDY ON INJECTION SNOREPLASTY CLAIMS THE TREATMENT IS EFFECTIVE AND HAS HIGH PATIENT SATISFACTION

New data indicate Injection Snoreplasty, a procedure that quiets snoring with a relatively painless and inexpensive shot in the upper palate, is as effective as other treatments.

Denver, CO -- Traditionally, primary snoring (snoring without sleep apnea) has been treated surgically through several options: Uvulopalatopharyngoplasty (UPPP) is an inpatient surgical option for sleep-apnea and snoring; laser-assisted uvulopalatoplasty (LAUP) consists of several laser treatments in an outpatient environment; and radiofrequency ablation (RFA) utilizes a needle electrode to emit energy to shrink excess tissue to the upper airway including the palate and uvula.

Last year, researchers from Walter Reed Army Medical Center introduced an experimental procedure called "Injection Snoreplasty." The procedure, performed in an otolaryngologist's office, involves the injection of Sotradecol, a sclerotherapy agent used to treat varicose veins, into the soft palate. This induces stiffening of the palate thereby reducing palatal flutter or primary snoring. Their conclusions labeled injection snoreplasty inexpensive and less painful than traditional surgical procedures used to reduce snoring.

The initial pilot study showed the technique to be effective as measured by subjective patient responses with follow-up up to a year. The authors presented their 18-24 month follow-up results on Monday, September 10, at the Annual Meeting of the American Academy of Otolaryngology -- Head and Neck Surgery Foundation being held at the Colorado Convention Center in Denver, CO. The authors of the study, "Injection Snoreplasty: Follow-up and New Objective Data," are Scott E. Brietzke, MD, and Eric A. Mair, MD, both from Walter Reed Army Medical Center in Washington, DC.

Methodology: The patients from the initial pilot study were re-evaluated. Clinical examinations, questionnaires, visual analog scales (VAS), and a comparative SF36 were used to assess long-term outcomes. Pilot study patients were given a standardized questionnaire that asked patients to express their overall satisfaction with the procedure, willingness to undergo the treatment again, and their inclination to recommend injection snoreplasty to others.

At the same time, a new group of patients diagnosed with primary snoring underwent the injection snoreplasty procedure. A take-home polysomnographic device (SNAP test) was performed before and after treatment to evaluate the amount of palatal snoring, palatal snoring loudness, palatal flutter frequency and average snoring loudness (in decibels).

Results: Twenty-two of 25 (88 percent) successfully treated patients completed the survey with an average follow-up period of 19 months. Four patients (16 percent) reported a relapse of their snoring after treatment, defined as a VAS score above 5. Three of four have been re-injected (one patient refused) and have resumed successful snoring treatment. The overall discomfort level from the procedure was reported to be 3.5 per the VAS. The overall satisfaction level was reported to be 8.1 of a possible 10. Twenty-one of 22 (95 percent) reported a willingness to undergo the procedure again and a willingness to recommend it to others, with most already having done so.

At the time of presentation, 15 new patients have been prospectively treated and have completed the pre and post-treatment SNAP Test. Thirteen of 15 (87 percent) patients reported subjective success with an average of 1.2 injections per patient. Eleven of 15 patients (73 percent) achieved objective success defined as improvement in three or more snoring measurements per the SNAP Test. Despite the incomplete and relatively small sample size, statistically significant reductions in the palatal snoring (Pre treatment mean = 85 percent, post = 64 percent, p < .05) and palatal loudness (pre-treatment mean = 9.1 dB, post = 3.5 dB, p < .05) measurements were observed. Improvement in the other measurements of average loudness (pre-treatment mean = 12.5 dB , post = 8.7 dB) and palatal flutter frequency (pre-treatment mean = 87 Hz, post = 105 Hz) were observed in the majority of patients but did not reach statistical significance.

Conclusion: The authors believe that Injection Snoreplasty has a relapse rate of 16 percent, which is comparable to other treatments for primary snoring. They assert that the procedure has the advantage of simplicity, minimal pain and inconvenience, and low cost. Nine out of ten patients are satisfied with the procedure and would undergo the treatment again or recommend it to others. Pre and post-procedure objective measurements confirm the procedure is effective in reducing the amount of palatal flutter snoring and the associated noise. Additional research in the areas of the use of alternative agents and treatment of obstructive sleep apnea are currently underway.

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Note: Injection snoreplasty is an experimental procedure. The findings delineated in this news release will undergo peer review by otolaryngologist--head and neck surgeons. Some ear, nose, and throat specialists will begin to administer the procedure at this time; others will wait until additional research is conducted before deciding to perform injection snoreplasty. Neither the American Academy of Otolaryngology nor Walter Reed Army Medical Center maintain a database that lists specialists who are now offering injection snoreplasty.

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