Herman Howard, Stern Jordan, Alessi David M, Swartz Keith A, Gillespie Marion Boyd
ENT of Georgia Atlanta Georgia USA.
Blue Sleep Center New York City New York USA.
OTO Open. 2023 Feb 17;7(1):e19. doi: 10.1002/oto2.19. eCollection 2023 Jan-Mar.
Investigate multilevel radiofrequency ablation (RFA) as an alternative therapy for patients with mild-to-moderate obstructive sleep apnea (OSA).
Prospective, open-label, single-arm, nonrandomized clinical trial.
Multicenter academic and private clinics.
Patients with mild-to-moderate OSA (apnea-hypopnea index [AHI] 10-30; body mass index ≤ 32) were treated with 3 sessions of office-based RFA to the soft palate and tongue base. The primary outcome was a change in the AHI and oxygen desaturation index (ODI 4%). Secondary outcomes included subjective sleepiness level; snoring level; and sleep-related quality of life.
Fifty-six patients were enrolled, with 43 (77%) completing the study protocol. Following 3 sessions of office-based RFA to the palate and base of the tongue, the mean AHI decreased from 19.7 to 9.9 ( = .001), while the mean ODI (4%) decreased from 12.8 to 8.4 ( = .005). Mean Epworth Sleepiness Scale scores declined from 11.2 (±5.4) to 6.0 (±3.5) ( = .001), while Functional Outcomes of Sleep Questionnaire scores improved from a mean of 14.9 at baseline to 17.4 ( = .001). The mean visual analog scale snoring scale was reduced from 5.3 (±1.4) at baseline to 3.4 (±1.6) at 6 months posttherapy ( = .001).
Office-based, multilevel RFA of the soft palate and base of the tongue is a safe and effective treatment option with minimal morbidity for properly selected patients with mild-to-moderate OSA who are intolerant or refuse continuous positive airway pressure therapy.
研究多级射频消融术(RFA)作为轻至中度阻塞性睡眠呼吸暂停(OSA)患者的替代治疗方法。
前瞻性、开放标签、单臂、非随机临床试验。
多中心学术和私人诊所。
轻至中度OSA患者(呼吸暂停低通气指数[AHI]为10 - 30;体重指数≤32)接受3次门诊软腭和舌根射频消融术治疗。主要结局指标为AHI和氧饱和度下降指数(ODI 4%)的变化。次要结局指标包括主观嗜睡程度、打鼾程度以及睡眠相关生活质量。
共纳入56例患者,43例(77%)完成研究方案。在接受3次门诊软腭和舌根射频消融术后,平均AHI从19.7降至9.9(P = 0.001),而平均ODI(4%)从12.8降至8.4(P = 0.005)。平均爱泼沃斯嗜睡量表评分从11.2(±5.4)降至6.0(±3.5)(P = 0.001),而睡眠问卷功能结局评分从基线时的平均14.9提高至17.4(P = 0.001)。平均视觉模拟量表打鼾评分从基线时的5.3(±1.4)降至治疗后6个月时的3.4(±1.6)(P = 0.001)。
对于不耐受或拒绝持续气道正压通气治疗的轻至中度OSA患者,门诊软腭和舌根多级射频消融术是一种安全有效的治疗选择,发病率极低。