Emery B E, Flexon P B
Division of Otolaryngology--Head and Neck Surgery, University of Maryland Medical System, Baltimore 21201, USA.
Laryngoscope. 2000 Jul;110(7):1092-8. doi: 10.1097/00005537-200007000-00005.
OBJECTIVE/HYPOTHESIS: Current options for the treatment of snoring have limited acceptance because of intolerance, expense, pain, or need for general anesthesia. A clinical trial using a new application of a previously known technology-radiofrequency energy-was investigated to determine its efficacy in the treatment of snoring. Effects of treatment on speech, swallowing, pain, snoring, and degree of sleepiness were evaluated. These effects were evaluated by post-treatment questionnaires.
Prospective nonrandomized study. All included subjects snored at a level considered bothersome to their bed partner. A total of 43 patients were enrolled at the University of Maryland (UM) and the Georgia Ear Institute (GEI). Polysomnography was performed before treatment to eliminate patients with significant sleep apnea who had respiratory disturbance indices (RDIs) greater than 15 or nadir desaturations less than 80%. The mean pretreatment RDI for all patients who entered the protocol at UM was 6.7 +/- 4.7. Nine patients completed the study in this group in all other aspects, but did not return for their scheduled post-treatment polysomnogram. At GEI, pretreatment polysomnograms revealed a mean RDI of 8.9 +/- 3.8. Eleven patients at GEI completed the study in all other aspects but did not return for their scheduled post-treatment polysomnogram. Radiofrequency energy was delivered to the soft palate either in the midline (19 patients) at a mean of 698 +/- 52 J per treatment at UM or in the midline and lateral soft palate (24 patients) at a mean of 1,254 +/- 191 J per treatment at GEI. At UM the mean age was 44.3 +/- 8.4 years, with a range from 29 to 59 years. Eighty-four percent of the patients were men. The mean body mass index (BMI) was 28.5 +/- 3.2. Twenty-four patients were enrolled at GEI. The mean age was 44.0 +/- 10.9 years, with a range from 23 to 63 years. Seventy-four percent of patients were men. The mean BMI was 27.7 +/- 3.8. Snoring, pain, swallowing, and speech were assessed after each treatment at post-treatment day 1, 2, or 3; week 1; week 4; and week 7. Daytime sleepiness was assessed by the Epworth Sleepiness Scores (ESS) obtained at the same intervals.
Snoring was improved in 77% of patients after three treatments or less. Seventy-nine percent of patients treated with the midline technique at UM and 96% of patients treated with the midline and left and right lateral palate technique at GEI achieved an improvement in their snoring to a level that was no longer bothersome to their bed partner. No persistent negative impact was noted concerning speech or swallowing. Improvements in degree of sleepiness were observed by comparing pretreatment and post-treatment ESS. ESS was significantly reduced (P < .005) after treatment from 10.2 +/- 6.1 to 6.1 +/- 4.7 at UM, and at the GEI, from 8.75 +/- 4.4 to 5.3 +/- 3.2. After a treatment, 27% of the patients at UM and 29% at GEI required analgesics.
This clinical trial demonstrates the efficacy, safety, and lack of pain encountered when using radiofrequency energy delivered to the palate for the treatment of snoring. The tolerability, lack of pain, and ability to perform the procedure with the patient under local anesthesia in the office make the use of this technology an excellent option for the treatment of snoring.
目的/假设:目前治疗打鼾的方法因不耐受、费用高、疼痛或需要全身麻醉而接受度有限。本研究对一项使用先前已知技术——射频能量的新应用的临床试验进行了调查,以确定其治疗打鼾的疗效。评估了治疗对言语、吞咽、疼痛、打鼾和嗜睡程度的影响。这些影响通过治疗后的问卷调查进行评估。
前瞻性非随机研究。所有纳入的受试者打鼾程度被认为会对其床伴造成困扰。马里兰大学(UM)和佐治亚耳科研究所(GEI)共招募了43名患者。治疗前进行多导睡眠图检查,以排除呼吸紊乱指数(RDI)大于15或最低血氧饱和度低于80%的严重睡眠呼吸暂停患者。在UM进入研究方案的所有患者的平均治疗前RDI为6.7±4.7。该组中有9名患者在其他所有方面完成了研究,但未返回进行预定的治疗后多导睡眠图检查。在GEI,治疗前多导睡眠图显示平均RDI为8.9±3.8。GEI的11名患者在其他所有方面完成了研究,但未返回进行预定的治疗后多导睡眠图检查。在UM,将射频能量输送至软腭中线(19例患者),每次治疗平均能量为698±52焦耳;在GEI,将射频能量输送至软腭中线及左右两侧(24例患者),每次治疗平均能量为±191焦耳。在UM,患者的平均年龄为44.3±8.4岁,范围为29至59岁。84%的患者为男性。平均体重指数(BMI)为28.5±3.2。GEI招募了24名患者。平均年龄为44.0±10.9岁,范围为23至63岁。74%的患者为男性。平均BMI为27.7±3.8。在治疗后第1、2或3天、第1周、第4周和第7周每次治疗后评估打鼾、疼痛、吞咽和言语情况。通过相同时间间隔获得的爱泼华嗜睡量表(ESS)评估白天嗜睡情况。
77%的患者在三次或更少次数的治疗后打鼾情况得到改善。在UM接受中线技术治疗的患者中,79%打鼾情况得到改善,在GEI接受中线及左右两侧软腭技术治疗的患者中,96%打鼾情况得到改善,改善至不再对其床伴造成困扰的程度。未发现对言语或吞咽有持续的负面影响。通过比较治疗前和治疗后的ESS,观察到嗜睡程度有所改善。在UM,治疗后ESS从10.2±6.1显著降低(P<.005)至6.1±4.7,在GEI,从8.75±4.4降低至5.3±3.2。治疗后,UM的27%患者和GEI的29%患者需要使用镇痛药。
本临床试验证明了使用输送至腭部的射频能量治疗打鼾时的疗效、安全性及无痛性。该技术的耐受性、无痛性以及能够在办公室对患者进行局部麻醉下操作,使其成为治疗打鼾的极佳选择。