Kwak Eunyee, Kwak Sangyeop
Sound Vaccine, Inc. Seoul Republic of Korea.
Laryngoscope Investig Otolaryngol. 2020 May 18;5(3):438-444. doi: 10.1002/lio2.399. eCollection 2020 Jun.
OBJECTIVES/HYPOTHESIS: Sensorineural hearing loss is one of the most common human disorders, with increasing incidence in elderly patients, severely restricting normal activities, and lowering quality of life. The introduction of sound conditioning has the potential to activate auditory pathway plasticity and improve basal frequency hearing. Our objective was to evaluate the safety and efficacy of threshold sound conditioning (TSC). The null hypothesis in this study was that TSC does not have a significant effect on auditory threshold amelioration.
Pure tone audiometry (PTA) was performed and hearing thresholds were measured once at baseline, and a second time following TSC intervention. Data were analyzed using an intention-to treat design.
The TSC group (78%) significantly differed from the control group (44%) on auditory threshold amelioration; = .008091 in DV1, = .000546 in DV2 by Scheffe's post hoc test. Female subjects (77%) showed a significant difference in DV1 from male subjects (47%); = .025468 in DV1 by Scheffe's post hoc test. Older subjects (75%) showed no significant difference from younger subjects (53%); = .139149 in DV1, = .082920 in DV2 by Scheffe's post hoc test.
We observed a significant improvement in a narrow band frequency threshold in this randomized controlled prospective clinical study in a broad range of subjects. These data have important clinical implications since there is no current long-term therapy for this widespread and growing disability. Additional physiologic, mechanistic, and molecular studies are necessary to fully elucidate the pathophysiology and mechanism of action of TSC.
1a.
目的/假设:感音神经性听力损失是人类最常见的疾病之一,在老年患者中的发病率不断上升,严重限制了正常活动并降低了生活质量。声音调节的引入有可能激活听觉通路可塑性并改善基频听力。我们的目的是评估阈下声音调节(TSC)的安全性和有效性。本研究的零假设是TSC对听觉阈值改善没有显著影响。
进行纯音听力测定(PTA),在基线时测量一次听力阈值,在TSC干预后再次测量。使用意向性治疗设计分析数据。
通过Scheffe事后检验,TSC组(78%)在听觉阈值改善方面与对照组(44%)有显著差异;DV1中P = 0.008091,DV2中P = 0.000546。女性受试者(77%)在DV1中与男性受试者(47%)有显著差异;通过Scheffe事后检验,DV1中P = 0.025468。老年受试者(75%)与年轻受试者(53%)无显著差异;通过Scheffe事后检验,DV1中P = 0.139149,DV2中P = 0.082920。
在这项针对广泛受试者的随机对照前瞻性临床研究中,我们观察到窄带频率阈值有显著改善。由于目前尚无针对这种广泛且不断增加的残疾的长期治疗方法,这些数据具有重要的临床意义。需要进行更多的生理、机制和分子研究,以充分阐明TSC的病理生理学和作用机制。
1a。