跳至主要内容
临床试验/NCT05644106
NCT05644106招募中不适用

Listening Benefits From a Hearing-aid App, a Personal Sound Amplification Product, and a Hearing Aid in Hearing-impaired Listeners

Seoul National University Hospital2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2021年8月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
The hearing level threshold (decibel) after each treatment

研究概览

简要总结

Interest and demand for sound amplifiers are increasing due to the burden of purchasing hearing aids and technological advances in healthcare products, and the demand is expected to increase rapidly. For sensorineural hearing loss patients, who are subject to wearing hearing aids, it aims to compare the effect of hearing aid application and personal sound amplification product (PSAPs) compared to the hearing aids

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults over the age of 20 who speak Korean as their mother tongue and have no mental or physical limitations in conducting test.
  • Hearing loss patients with a hearing threshold of 26 dB or higher in the four frequency (0.5, 1, 2, 4 kHz)
  • Those who do not have a history of neurological disease, cognitive disorder, learning disorder, or language disorder at the time of recruitment

排除标准

  • In case that communication is difficult, equipment cannot be handled, or it is difficult to cooperate with the inspection
  • Acoustic nerve lesions or central nervous system disease
  • Those suspected of having false hearing loss
  • Those who have secondary benefits related to clinical trials

结局指标

主要结局

The hearing level threshold (decibel) after each treatment

时间窗: 1 month

The comparison of hearing threshold, which is calculated as mean decibel on four frequencies, among different treatments

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Moo Kyun, Park

Professor

Seoul National University Hospital

研究点 (2)

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