跳至主要内容
临床试验/CTRI/2023/08/056957
CTRI/2023/08/056957尚未招募不适用

Influence of Recreational Noise Exposure on Cochlear Synaptic Functions in College-Going Students

Michal Jacob1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2023年1月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
132
试验地点
1
主要终点
NESI- total units of noise exposure,

研究概览

简要总结

Aim: To study the influence of recreational noise exposure on cochlear synaptic functions in college-going students.

Objectives:

  1. To estimate the recreational noise exposure levels
  2. To assess the influence of recreational noise on ABR wave I latency, amplitude and FFR
  3. To study the association between recreational noise exposure and ABR and FFR

Justification for study: Listening difficulty and poor speech perception is common in cochlear synaptopathy, which is also reported by chronic recreational noise exposure individuals. However, till date the relationship is not established. Hence there is a need to see the influence and association of recreational noise and synaptic function.

Procedure: This study involves the administration of the Noise Exposue Structured Interview (Guest et al, 2018) to estimate a person’s lifetime noise exposure. After this individuals are grouped into 3 groups. Group 1- No noise/ occasional users of PLDs or recreational noise exposure, 2- Predominant PLD users, 3- Combined PLD and recreational noise exposure. Then Pure Tone Audiometry along with Extended High Frequency Audiometry and Speech-in-noise test are done. Otoacoustic emissions, Electrocochleography, ABR and Frequency Following Response will also be done.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • College going students between 18-30 years of age.

排除标准

  • Individuals with middle ear problems.
  • Pre-existing hearing loss.
  • Neurological or medical conditions that influence auditory and cognitive functions.

结局指标

主要结局

NESI- total units of noise exposure,

时间窗: 11 months 19 days

Electrophysiological measure -Amplitude (microvolt) / latency of wave I (millisecond),

时间窗: 11 months 19 days

FFR peaks latency (millisecond),

时间窗: 11 months 19 days

SP/AP ratio

时间窗: 11 months 19 days

次要结局

  • Association between recreational noise exposure & FFR(11 months 19 days)

研究者

发起方
Michal Jacob
申办方类型
Other [self]

研究点 (1)

Loading locations...

相似试验

Effects of recreational noise on auditory listening... | 临床试验