Speech Perception, Spatial Perception and Satisfaction Outcomes of Fitting Based on Hearing In Noise Ability
2026年8月8日 更新者：Melek Başak ÖZKAN、Istanbul Aydın University
Hearing speech in the presence of background noise is a significant challenge for those with hearing loss.
Being able to hear speech in noise has been rated as the most sought-after feature in hearing aids by hearing aid users.
Our study aims to evaluate the effects of adaptation to hearing test in noise on speech perception, spatial perception and satisfaction in bilateral hearing aid users.
The development process of speech understanding in noise in individuals with hearing loss over the age of 50 will be monitored with ACT and ecological-HINT tests.
Spatial perception will be assessed with the Speech, Spatial Perception and Hearing Quality (SHRQ) Scale, which is a scale that evaluates the current hearing quality in adults.
The hearing aid satisfaction process of the participants will be assessed with the APHAB survey.
研究概览
详细说明
Hypotheses:
H0: Using ACT in the fitting is not more effective than the traditional fitting method in improving speech understanding performance in noise in hearing aid users.
H1: Using ACT in the fitting is more effective than the traditional fitting method in improving speech understanding performance in noise in hearing aid users.
H0: Using ACT in the fitting is not more effective than the traditional fitting method in improving spatial perception performance in hearing aid users.
H1: Using ACT in the fitting is more effective than the traditional fitting method in improving spatial perception performance in hearing aid users.
H0: Using ACT in the fitting does not increase speech understanding performance in noise in hearing aid users.
H1: Using ACT in the fitting increases speech understanding performance in noise in hearing aid users.
H0: Using ACT in the fitting has no effect on improving spatial perception performance in hearing aid users.
H1: Using ACT in the fitting has an effect on improving spatial perception performance in hearing aid users.
H0: Using ACT in fitting has no effect on increasing hearing aid satisfaction in hearing aid users.
H1: Using ACT in fitting has an effect on increasing hearing aid satisfaction in hearing aid users.
研究类型
介入性
注册 (实际的)
42
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Kucukcekmece
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Istanbul、Kucukcekmece、土耳其（türkiye）、34295
- Istanbul Aydın University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Medium (41-55 dB) / moderate to severe (56-70 dB), sensorineural hearing loss (Goodman, 1965)
- SDS score between 70-100%
- Being a bilateral hearing aid user
- Being a user of Oticon, Philips, Bernafon hearing aids
- Being between 18-50 years of age
- Signing an informed consent form
Exclusion Criteria:
- Conditions with variable hearing loss such as Meniere's disease, ongoing treatment with ototoxic drugs
- Complaining with tinnitus
- Low cognitive capacity: Scoring below 24 on the Standardized Mini Mental Test
- Not signing an informed consent form
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Experimental Group
The ACT method will be applied to the study group in fitting, and the results will be recorded by applying the KUİK scale and APHAB survey after fitting.
They will be called for control in the 1st week and 1st month, and fitting and scale evaluations will be made and the results will be recorded.
Participants' discrimination in noise with ACT and Turkish Matrix Test, evaluation of spatial perception with the KUİK scale, and hearing aid satisfaction with the APHAB survey will be evaluated in the initial and 1st month time periods.
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The ACT diagnostic test is a suprathreshold, non-language-specific test that measures an individual's hearing ability in real-world noisy environments to determine the level of assistance needed in noise.
The test uses the audiogram shape and levels to ensure the correct stimulus intensity is applied.
The ACT test then uses the patient's audiogram to present a suprathreshold stimulus (a siren-like sound) to objectively map their hearing ability in noisy environments.
In other words, the audiogram measures quantity, i.e. hearing ability, while the ACT measures the quality of hearing.
This makes the ACT a robust assessment that reflects an individual's real-world hearing abilities.
其他名称：
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有源比较器：Control Group
The control group will be fitted with traditional fittings, and the results will be recorded using the KUİK scale and APHAB survey after fitting.
Fitting and scale assessments will be made at week 1 and month 1, and the results will be recorded.
Participants' ability to discriminate in noise with the ACT and Turkish Matrix Test, spatial perception assessment with the KUİK scale, and hearing aid satisfaction with the APHAB survey will be assessed at the beginning and month 1.
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The control group will be fitted with traditional fittings, and the results will be recorded using the KUİK scale and APHAB survey after fitting.
They will be called for a check-up at week 1 and month 1, and fitting and scale assessments will be made, and the results will be recorded.
Participants' ability to discriminate in noise with the ACT and Turkish Matrix Test, spatial perception with the KUİK scale, and hearing aid satisfaction with the APHAB survey will be assessed at the beginning and month 1.
All findings will be compared and statistically analyzed.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Eco-HINT
大体时间：1 week and 1 month after hearing aid fitting
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Speech-in-noise performance was assessed using the ecologically valid Hearing in Noise Test (eco-HINT).
Speech reception thresholds were measured under aided and unaided listening conditions.
Lower scores indicate better speech-in-noise performance.
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1 week and 1 month after hearing aid fitting
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Speech, Spatial Perception and Hearing Quality Scale
大体时间：1 week and 1 month after hearing aid fitting
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The individual who is applied the scale evaluates himself/herself and answers each question between 0 and 10 points.
All scores are added up and divided by 49 to obtain the "General KUİK score".
The scores under the heading of Speech Perception are added up and divided by 14 to obtain the KA score, the scores under the heading of Spatial Perception are added up and divided by 17 to obtain the UA score, and the scores under the heading of Hearing Quality are added up and divided by 18 to obtain the İK score.
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1 week and 1 month after hearing aid fitting
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APHAB survey
大体时间：1 week and 1 month after hearing aid fitting
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APHAB is a survey that allows us to numerically measure the benefits and satisfaction of individuals with hearing loss from their hearing aids in daily hearing situations.
Survey questions are answered according to two different listening situations: "without my hearing aid" and "with my hearing aid".
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1 week and 1 month after hearing aid fitting
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Audible Contrast Threshold (ACT)
大体时间：Time Frame: 1 week and 1 month after hearing aid fitting
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The ACT is a suprathreshold, non-language-specific test that measures an individual's ability to hear in real-world noisy environments to determine the level of assistance needed in noise.
ACT values are determined by level of intensity.
A normal ACT value is between -4 and +4 dB nCL. 4 to 7 dB nCL indicates mild loss, 7 to 10 dB nCL indicates moderate loss, and 10 to 16 dB nCL indicates profound loss.
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Time Frame: 1 week and 1 month after hearing aid fitting
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Sule Cekic, associate professor、Ankara Yildirim Beyazıt University
- 研究主任：Umıt Can Cetinkaya, assistant professor、Istanbul Aydın University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年2月13日
初级完成 (实际的)
2025年5月2日
研究完成 (实际的)
2025年6月1日
研究注册日期
首次提交
2025年3月31日
首先提交符合 QC 标准的
2026年8月8日
首次发布 (实际的)
2026年8月11日
研究记录更新
最后更新发布 (实际的)
2026年8月11日
上次提交的符合 QC 标准的更新
2026年8月8日
最后验证
2026年3月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 61351342/020-385
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
To ensure the privacy and confidentiality of participants, individual participant data (IPD) will not be shared.
Since the study involves hearing aid users, it is extremely important to protect the integrity of their personal data.
Furthermore, the guidelines of the ethics committee and institutional policies require strict data protection to prevent possible misuse.
Therefore, IPD will remain confidential and will not be made public.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.