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临床试验/NCT01781039
NCT01781039
已完成
不适用

Investigation of Anatomical Correlates of Speech Discrimination

Steward St. Elizabeth's Medical Center of Boston, Inc.1 个研究点 分布在 1 个国家目标入组 186 人2013年1月1日

概览

阶段
不适用
干预措施
Hearing Aid fitting
疾病 / 适应症
Sensorineural Hearing Loss
发起方
Steward St. Elizabeth's Medical Center of Boston, Inc.
入组人数
186
试验地点
1
主要终点
Regression analysis
状态
已完成
最后更新
上个月

概览

简要总结

Understanding speech is essential for good communication. Individuals with hearing loss and poor speech discrimination often have little success with hearing aids because amplifying sound improves audibility, but not clarity of the speech signal. The purpose of this study is to determine the relative importance of the sensory cells of the inner ear and auditory neurons on speech discrimination performance in quiet and in noise. This information may be used as a predictor of hearing aid benefit. The investigators expect to find decreased speech understanding ability resulting from both loss of sensory cells and the loss of auditory neurons.

详细描述

Patients receiving routine audiologic evaluations who meet study criteria will be asked to participate in the study. Study participants will receive an ABR and DPOAE evaluation and speech-in-noise testing. Participants who are hearing aid candidates will be fit with loaner hearing aids with noise reduction technology for 2 weeks. Wave 1 amplitudes from the ABR, DPOAE levels, speech discrimination scores, unaided and aided speech0in-noise performance age, and pure tone thresholds will be recorded, as well as any audiologic diagnosis that may confound the results.

注册库
clinicaltrials.gov
开始日期
2013年1月1日
结束日期
2019年12月12日
最后更新
上个月
研究类型
Observational
性别
All

研究者

责任方
Sponsor
主要研究者

Mark Parker

Director of Audiology, St. Elizabeth's Medical Center

Steward St. Elizabeth's Medical Center of Boston, Inc.

入排标准

入选标准

  • Normal hearing to moderate sensorineural hearing loss
  • Sufficient English proficiency to complete speech discrimination testing in English

排除标准

  • Hearing loss less than a 45 dB HL pure tone average (average hearing thresholds at 500, 1000 and 2000 Hz)
  • Conductive hearing loss
  • Neurodegenerative disease

研究组 & 干预措施

Hearing Aid fitting: Negative control

All hearing aid features disabled

干预措施: Hearing Aid fitting

low HIN difficulty- anesthetized

Subjects with normal OHC function and who will be undergoing an previously scheduled anesthetized procedure will be assigned into 2 groups based on their self-perceived HIN difficulty (high and low difficulty), and then undergo a test battery consisting of auditory threshold tests, objective HIN assays, OHC measurements, cognitive processing, and central auditory processing evaluations. Immediately after anesthetization, electrocochleography (ECochG) will be used to measure CAP amplitudes, which will be correlated with measurements obtained from unanesthetized subjects as described below. This aim will determine the optimal CAP recording method with the strongest correlation with HIN performance in humans

high HIN difficulty- anesthetized

Subjects with normal OHC function and who will be undergoing an previously scheduled anesthetized procedure will be assigned into 2 groups based on their self-perceived HIN difficulty (high and low difficulty), and then undergo a test battery consisting of auditory threshold tests, objective HIN assays, OHC measurements, cognitive processing, and central auditory processing evaluations. Immediately after anesthetization, electrocochleography (ECochG) will be used to measure CAP amplitudes, which will be correlated with measurements obtained from unanesthetized subjects as described below. This aim will determine the optimal CAP recording method with the strongest correlation with HIN performance in humans

Hearing Aid fitting: MAD

Microphone adaptive directionality (MAD) feature will be activated, the WDC set to linear, and the DNR minimized

干预措施: Hearing Aid fitting

Hearing Aid fitting: WDC

Wide dynamic compression (WDC) feature will be set to target levels, the MAD feature set to omnidirectional, and the DNR minimized.

干预措施: Hearing Aid fitting

Hearing Aid fitting: DNR

Digital noise reduction (DNR) set to maximum, MAD set to omnidirectional, and WDC set to linear

干预措施: Hearing Aid fitting

Hearing Aid fitting: Positive control

All hearing aid features enables

干预措施: Hearing Aid fitting

结局指标

主要结局

Regression analysis

时间窗: June 2024

Regression analysis will be used to look for a correlation between measures of sensory cell and auditory neuron survival and speech recognition performance.

研究点 (1)

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