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临床试验/NCT05076344
NCT05076344已完成不适用

Understanding the Consequences of Recreational Noise Exposure

University of Nottingham2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年5月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
2
主要终点
Auditory nerve health

研究概览

简要总结

The aim of this study is to determine whether measures derived from Magnetic Resonance Imaging (MRI) scans, and clinical and behavioural measures of hearing loss, in the peripheral and central auditory system (ranging from the cochlear nerve through the auditory brainstem to the auditory cortex) are associated with age and history of noise exposure in otherwise healthy adult humans.

详细描述

Noise exposure is the main cause of preventable hearing loss worldwide. Noise exposure occurs in the workplace, such as in noisy factories, and recreationally through the use of personal music players and attendance at nightclubs and live music events.

Hearing loss is usually diagnosed using pure tone audiometry, which measures the sensitivity of the ear to quiet sounds by determining the levels of tones that can just be heard at several test frequencies. Until recently, it had been assumed that hearing loss results mainly from damage to the sensory hair cells in the cochlea, the part of the ear that converts acoustic vibrations into electrical impulses in the cochlear nerve (CN). However, recent results from animal studies suggest that even moderate noise exposure can cause substantial damage to the CN, without any noticeable damage to the hair cells. Crucially, these results suggest that such damage does not immediately affect sensitivity to quiet sounds, but may exacerbate the effects of ageing.

Hearing loss is a huge problem. Substantial numbers of people, millions in the United Kingdom (UK) alone, are routinely exposed to significant levels of occupational and/or recreational noise. A large UK study found that one in seven adults aged 17-30 years reported "great difficulty" hearing speech in noisy backgrounds, while only one in fifty had impaired sensitivity as measured by pure tone audiometry. Hearing loss can lead to social isolation, depression, and is likely to be predictive of more severe hearing loss in old age. Recent studies suggest that hearing loss also reduces quality of life and is a risk factor for dementia.

This study is part of a programme grant conducted from April 2021 to March 2026 by The University of Manchester and The University of Nottingham. The overall aim of the programme is to understand the consequences of recreational noise exposure through improvement of the understanding of the contribution of CN damage to listening difficulties and audiometric losses.

The primary research questions are:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Ability to give informed consent in English
  • In the age range stipulated for the group, i.e. 18-19 inclusive for group 1 and 30-50 inclusive for groups 2 -
  • Audiometric thresholds in the range stipulated for the group, i.e. in the normal range for their age group for groups 1 - 3 and outside the normal range for their age group for group
  • Noise exposure in the range stipulated for the group, as determined by the NESI, i.e. less than 15 units for groups 1 - 2 and 15 or more units for groups 3 - 4.

排除标准

  • Contraindications for MRI
  • Motor impairment (for example, cerebral palsy)
  • Cognitive impairment (for example, dementia or brain injury)
  • Health conditions indicative of peripheral neuropathy (e.g. Type 1 diabetes).

结局指标

主要结局

Auditory nerve health

时间窗: Baseline

Diffusion measure in the auditory nerve (fractional anisotropy or apparent diffusion coefficient)

次要结局

  • Anatomical measure of the ascending auditory pathway(Baseline)
  • Functional measure of the ascending auditory pathway(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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