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临床试验/CTRI/2025/03/082719
CTRI/2025/03/082719尚未招募不适用

Development and Validation of Behavioural Measure of Listening Effort for Adults in Kannada

KMC Manipal1 个研究点 分布在 1 个国家目标入组 369 人开始时间: 2025年4月20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
369
试验地点
1
主要终点
Phase 1: WIRT Development and Validation

研究概览

简要总结

The study aims to develop and validate behavioural and self-reported listening effort measures tailored for Kannada-speaking adults. It involves the creation of a novel Word Identification and Recall Test (WIRT) and the translation and validation of the Extended Effort Assessment Scale (EEAS) into Kannada. The study also aims to establish normative baselines and evaluate these tools among normal-hearing and hearing-impaired populations.Listening effort can be reliably measured and validated in Kannada-speaking adults through behavioural paradigms like the WIRT and self-reported measures like the EEAS, enabling improved clinical assessment of listening effort in hearing-impaired individuals.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 59.00 Year(s)(—)
性别
All

入选标准

  • Aged 18 to 59 years Normal hearing (thresholds better than 25 dB HL) have normal middle ear functioning.
  • Hearing Impaired Group:Hearing sensitivity better than 25 dB HL up to severe hearing loss (up to 70 dB HL) Primary language is Kannada MoCA score of at least 26 Individuals should have at least an 8th grade level of education.
  • Normal vision or corrected vision.

排除标准

  • History of sensory deficits (including vision and Hearing) Any neurological conditions & psychological illness.

结局指标

主要结局

Phase 1: WIRT Development and Validation

时间窗: Phase 1: WIRT Development and Validation | Accuracy: Percentage of correctly identified words in the WIRT. | Reaction Time: Speed of response to auditory stimuli (ms). | Item Difficulty: Performance metrics to refine word difficulty levels. | Phase 2: Translation and Validation of Behavioral Measures | Listening Effort: Self-reported scores on a 10-question Visual Analog Scale (VAS). | Translation Accuracy: Accuracy in translating the EEAS questionnaire. | Internal Consistency: Reliability of the EEAS (Cronbach’s alpha). | Phase 3: Normative Estimation and Validation | Normative Baselines: WIRT performance data from 200 participants. | Group Comparisons: Differences in WIRT performance and listening effort between normal-hearing and hearing-impaired groups (27 participants each).

Accuracy: Percentage of correctly identified words in the WIRT.

时间窗: Phase 1: WIRT Development and Validation | Accuracy: Percentage of correctly identified words in the WIRT. | Reaction Time: Speed of response to auditory stimuli (ms). | Item Difficulty: Performance metrics to refine word difficulty levels. | Phase 2: Translation and Validation of Behavioral Measures | Listening Effort: Self-reported scores on a 10-question Visual Analog Scale (VAS). | Translation Accuracy: Accuracy in translating the EEAS questionnaire. | Internal Consistency: Reliability of the EEAS (Cronbach’s alpha). | Phase 3: Normative Estimation and Validation | Normative Baselines: WIRT performance data from 200 participants. | Group Comparisons: Differences in WIRT performance and listening effort between normal-hearing and hearing-impaired groups (27 participants each).

Reaction Time: Speed of response to auditory stimuli (ms).

时间窗: Phase 1: WIRT Development and Validation | Accuracy: Percentage of correctly identified words in the WIRT. | Reaction Time: Speed of response to auditory stimuli (ms). | Item Difficulty: Performance metrics to refine word difficulty levels. | Phase 2: Translation and Validation of Behavioral Measures | Listening Effort: Self-reported scores on a 10-question Visual Analog Scale (VAS). | Translation Accuracy: Accuracy in translating the EEAS questionnaire. | Internal Consistency: Reliability of the EEAS (Cronbach’s alpha). | Phase 3: Normative Estimation and Validation | Normative Baselines: WIRT performance data from 200 participants. | Group Comparisons: Differences in WIRT performance and listening effort between normal-hearing and hearing-impaired groups (27 participants each).

Item Difficulty: Performance metrics to refine word difficulty levels.

时间窗: Phase 1: WIRT Development and Validation | Accuracy: Percentage of correctly identified words in the WIRT. | Reaction Time: Speed of response to auditory stimuli (ms). | Item Difficulty: Performance metrics to refine word difficulty levels. | Phase 2: Translation and Validation of Behavioral Measures | Listening Effort: Self-reported scores on a 10-question Visual Analog Scale (VAS). | Translation Accuracy: Accuracy in translating the EEAS questionnaire. | Internal Consistency: Reliability of the EEAS (Cronbach’s alpha). | Phase 3: Normative Estimation and Validation | Normative Baselines: WIRT performance data from 200 participants. | Group Comparisons: Differences in WIRT performance and listening effort between normal-hearing and hearing-impaired groups (27 participants each).

Phase 2: Translation and Validation of Behavioral Measures

时间窗: Phase 1: WIRT Development and Validation | Accuracy: Percentage of correctly identified words in the WIRT. | Reaction Time: Speed of response to auditory stimuli (ms). | Item Difficulty: Performance metrics to refine word difficulty levels. | Phase 2: Translation and Validation of Behavioral Measures | Listening Effort: Self-reported scores on a 10-question Visual Analog Scale (VAS). | Translation Accuracy: Accuracy in translating the EEAS questionnaire. | Internal Consistency: Reliability of the EEAS (Cronbach’s alpha). | Phase 3: Normative Estimation and Validation | Normative Baselines: WIRT performance data from 200 participants. | Group Comparisons: Differences in WIRT performance and listening effort between normal-hearing and hearing-impaired groups (27 participants each).

Listening Effort: Self-reported scores on a 10-question Visual Analog Scale (VAS).

时间窗: Phase 1: WIRT Development and Validation | Accuracy: Percentage of correctly identified words in the WIRT. | Reaction Time: Speed of response to auditory stimuli (ms). | Item Difficulty: Performance metrics to refine word difficulty levels. | Phase 2: Translation and Validation of Behavioral Measures | Listening Effort: Self-reported scores on a 10-question Visual Analog Scale (VAS). | Translation Accuracy: Accuracy in translating the EEAS questionnaire. | Internal Consistency: Reliability of the EEAS (Cronbach’s alpha). | Phase 3: Normative Estimation and Validation | Normative Baselines: WIRT performance data from 200 participants. | Group Comparisons: Differences in WIRT performance and listening effort between normal-hearing and hearing-impaired groups (27 participants each).

Translation Accuracy: Accuracy in translating the EEAS questionnaire.

时间窗: Phase 1: WIRT Development and Validation | Accuracy: Percentage of correctly identified words in the WIRT. | Reaction Time: Speed of response to auditory stimuli (ms). | Item Difficulty: Performance metrics to refine word difficulty levels. | Phase 2: Translation and Validation of Behavioral Measures | Listening Effort: Self-reported scores on a 10-question Visual Analog Scale (VAS). | Translation Accuracy: Accuracy in translating the EEAS questionnaire. | Internal Consistency: Reliability of the EEAS (Cronbach’s alpha). | Phase 3: Normative Estimation and Validation | Normative Baselines: WIRT performance data from 200 participants. | Group Comparisons: Differences in WIRT performance and listening effort between normal-hearing and hearing-impaired groups (27 participants each).

Internal Consistency: Reliability of the EEAS (Cronbach’s alpha).

时间窗: Phase 1: WIRT Development and Validation | Accuracy: Percentage of correctly identified words in the WIRT. | Reaction Time: Speed of response to auditory stimuli (ms). | Item Difficulty: Performance metrics to refine word difficulty levels. | Phase 2: Translation and Validation of Behavioral Measures | Listening Effort: Self-reported scores on a 10-question Visual Analog Scale (VAS). | Translation Accuracy: Accuracy in translating the EEAS questionnaire. | Internal Consistency: Reliability of the EEAS (Cronbach’s alpha). | Phase 3: Normative Estimation and Validation | Normative Baselines: WIRT performance data from 200 participants. | Group Comparisons: Differences in WIRT performance and listening effort between normal-hearing and hearing-impaired groups (27 participants each).

Phase 3: Normative Estimation and Validation

时间窗: Phase 1: WIRT Development and Validation | Accuracy: Percentage of correctly identified words in the WIRT. | Reaction Time: Speed of response to auditory stimuli (ms). | Item Difficulty: Performance metrics to refine word difficulty levels. | Phase 2: Translation and Validation of Behavioral Measures | Listening Effort: Self-reported scores on a 10-question Visual Analog Scale (VAS). | Translation Accuracy: Accuracy in translating the EEAS questionnaire. | Internal Consistency: Reliability of the EEAS (Cronbach’s alpha). | Phase 3: Normative Estimation and Validation | Normative Baselines: WIRT performance data from 200 participants. | Group Comparisons: Differences in WIRT performance and listening effort between normal-hearing and hearing-impaired groups (27 participants each).

Normative Baselines: WIRT performance data from 200 participants.

时间窗: Phase 1: WIRT Development and Validation | Accuracy: Percentage of correctly identified words in the WIRT. | Reaction Time: Speed of response to auditory stimuli (ms). | Item Difficulty: Performance metrics to refine word difficulty levels. | Phase 2: Translation and Validation of Behavioral Measures | Listening Effort: Self-reported scores on a 10-question Visual Analog Scale (VAS). | Translation Accuracy: Accuracy in translating the EEAS questionnaire. | Internal Consistency: Reliability of the EEAS (Cronbach’s alpha). | Phase 3: Normative Estimation and Validation | Normative Baselines: WIRT performance data from 200 participants. | Group Comparisons: Differences in WIRT performance and listening effort between normal-hearing and hearing-impaired groups (27 participants each).

Group Comparisons: Differences in WIRT performance and listening effort between normal-hearing and hearing-impaired groups (27 participants each).

时间窗: Phase 1: WIRT Development and Validation | Accuracy: Percentage of correctly identified words in the WIRT. | Reaction Time: Speed of response to auditory stimuli (ms). | Item Difficulty: Performance metrics to refine word difficulty levels. | Phase 2: Translation and Validation of Behavioral Measures | Listening Effort: Self-reported scores on a 10-question Visual Analog Scale (VAS). | Translation Accuracy: Accuracy in translating the EEAS questionnaire. | Internal Consistency: Reliability of the EEAS (Cronbach’s alpha). | Phase 3: Normative Estimation and Validation | Normative Baselines: WIRT performance data from 200 participants. | Group Comparisons: Differences in WIRT performance and listening effort between normal-hearing and hearing-impaired groups (27 participants each).

次要结局

  • 1. Assess differences in listening effort between hearing-impaired participants & normal-hearing participants using the Word Identification & Recall Test (WIRT) & Extended Effort Assessment Scale (EEAS).(2.Investigate electrophysiological markers during the WIRT task in normal-hearing participants.)

研究者

发起方
KMC Manipal
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Bhavana R

Manipal College of Health Professions

研究点 (1)

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