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CLINICAL TRIAL
JOURNAL ARTICLE
RESEARCH SUPPORT, NON-U.S. GOV'T
Midline radiofrequency tissue reduction of the palate for bothersome snoring and sleep-disordered breathing: A clinical trial.
Otolaryngology - Head and Neck Surgery 2000 March
This study is a prospective, nonrandomized clinical trial initiated to assess the safety and efficacy of radiofrequency tissue reduction of the palate for the treatment of bothersome snoring and sleep-disordered breathing. Twelve healthy volunteers with socially disruptive snoring underwent a baseline polysomnogram along with a battery of visual analog scales (VASs) to measure daytime sleepiness, snoring level, pain, and disturbances of speech and swallowing. After radiofrequency tissue reduction of the palate, they were re-evaluated with a mean follow-up after the final procedure of 15.7 +/- 5.1 (mean +/- SD) weeks. As rated by the bed partner, a significant reduction in the level of snoring occurred in all 12 patients, with a mean pretreatment snoring level of 8.3 +/- 2.1 to a mean posttreatment snoring level of 2.1 +/- 1.4. (Student t test, P < 0.0001) These patients required an average of 2.3 treatment sessions each. Nine of 12 had a reduction in snoring from a bothersome level (VAS range 5-10) to a nonbothersome level (VAS range 0-3). Daytime sleepiness as measured by the Epworth Sleepiness Scale (0-24) decreased from 10.8 +/- 4.4 to 8.3 +/- 4.1 (P = 0.011). Posttreatment pain was considered absent or minimal in 11 of 12 patients and was managed with acetaminophen. No significant adverse events or complications were reported.
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