Digital Music Exposure Reliably Induces Temporary Threshold Shift in Normal-Hearing Human Subjects
Digital Music Exposure Reliably Induces Temporary Threshold Shift in Normal-Hearing Human Subjects
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DOI：
10.1097/aud.0b013e31825f9d89
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发表时间：
2012-11-01
期刊：
影响因子：
3.7
通讯作者：
Guire, Kenneth
中科院分区：
文献类型：
--
作者：
Le Prell, Colleen G.;Dell, Shawna;Guire, Kenneth
目的：评估新的耳保护剂在人群中的潜在益处的挑战之一是具有现实世界相关性的已建立的临床范例的可用性。这些研究的目的是明确开发一个真实世界的数字音乐曝光，可靠地诱导暂时性阈值偏移（TTS）在正常听力人类subjects.Design：33名受试者参加了研究，测量数字音乐播放器的使用对听力的影响。受试者选择摇滚乐或流行音乐，然后在93至95（n = 10），98至100（n = 11），或100至102（n = 12）dBA的耳内暴露水平为4 hr. Audigrams和畸变产物耳声发射（DPOAEs）进行了测量之前和之后的音乐曝光。在暴露结束后15分钟、1小时15分钟、2小时15分钟和3小时15分钟开始音乐后测试。额外的测试进行了第二天和1 week later.Results：阈值的变化后，最低水平的曝光是难以区分的重测变异，但是，TTS可靠地检测后，更高水平的声音曝光。测听阈值的变化具有“缺口”结构，在4 kHz时观察到最大变化（平均值= 6.3 +/- 3.9 dB;范围= 0-14 dB）。恢复基本上是完整的第一个4小时postexhalation，和所有的科目都显示出完全恢复的阈值和DPOAE措施时，测试1周postexhalation.Conclusions：这些数据提供了深入了解TTS的变化引起的音乐播放器的使用在一个健康的，正常的听力，年轻的成年人的人口，与音乐播放列表，水平和持续时间仔细控制。这些数据证实了使用数字音乐播放器后听觉功能暂时变化的可能性。这些数据对于开发人体临床试验方案至关重要，该方案提供了用于在人体临床试验中评价新疗法的高效力设计。在未来的TTS研究中，包括保护剂评价，必须注意充分告知潜在受试者，某些噪声暴露已导致动物模型中的神经变性，即使听力阈值和DPOAE水平均恢复到暴露前值。
Objectives: One of the challenges for evaluating new otoprotective agents for potential benefit in human populations is the availability of an established clinical paradigm with real-world relevance. These studies were explicitly designed to develop a real-world digital music exposure that reliably induces temporary threshold shift (TTS) in normal-hearing human subjects.Design: Thirty-three subjects participated in studies that measured effects of digital music player use on hearing. Subjects selected either rock or pop music, which was then presented at 93 to 95 (n = 10), 98 to 100 (n = 11), or 100 to 102 (n = 12) dBA in-ear exposure level for a period of 4 hr. Audiograms and distortion product otoacoustic emissions (DPOAEs) were measured before and after music exposure. Postmusic tests were initiated 15 min, 1 hr 15 min, 2 hr 15 min, and 3 hr 15 min after the exposure ended. Additional tests were conducted the following day and 1 week later.Results: Changes in thresholds after the lowest-level exposure were difficult to distinguish from test-retest variability; however, TTS was reliably detected after higher levels of sound exposure. Changes in audiometric thresholds had a "notch" configuration, with the largest changes observed at 4 kHz (mean = 6.3 +/- 3.9 dB; range = 0-14 dB). Recovery was largely complete within the first 4 hr postexposure, and all subjects showed complete recovery of both thresholds and DPOAE measures when tested 1 week postexposure.Conclusions: These data provide insight into the variability of TTS induced by music-player use in a healthy, normal-hearing, young adult population, with music playlist, level, and duration carefully controlled. These data confirm the likelihood of temporary changes in auditory function after digital music-player use. Such data are essential for the development of a human clinical trial protocol that provides a highly powered design for evaluating novel therapeutics in human clinical trials. Care must be taken to fully inform potential subjects in future TTS studies, including protective agent evaluations, that some noise exposures have resulted in neural degeneration in animal models, even when both audiometric thresholds and DPOAE levels returned to pre-exposure values.