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临床试验/CTRI/2025/07/091801
CTRI/2025/07/091801尚未招募不适用

Relationship between subjective and objective Listening-related fatigue in adults.

Diya Deepak1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月17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
30
试验地点
1
主要终点
1) aPVT -Objective listening-related fatigue score.

研究概览

简要总结

Listening-related fatigue is associated with a sustained effort given to a task involving listening and can be measured both subjectively and objectively. Initially Institutional Research Committee, MCHP approval would be taken followed by the Institutional Ethics Committee, KH Manipal approval, and Registration in Clinical Trial Registry- India. Participants will be recruited from outpatients in the Department of Speech and Hearing at KMC Hospital and individuals in and around the hospital, who are willing to participate, based on their availability. The study will include an explanation of the procedures and the collection of informed consent. Potential participants will be screened according to the established inclusion and exclusion criteria. Patients who pass the audiometric screening and Montreal Cognitive Assessment (MoCA ®) will undergo the administration of the VFS in its Kannada version. Further, the aPVT test will be administered using E-Prime software on a laptop running Windows 11.

Aim and Objective: To explore the relationship between subjective and objective Listening-related fatigue in adults.

Justification of the study: This study may help bridge the gap or understanding between self-reported and objective performance measures, guiding us to understand fatigue better. Listening-related fatigue is primarily a subjective experience, and current assessments rely exclusively on subjective tools. To better understand the various dimensions of fatigue, it is essential to explore the correlation between the Voice Fatigue Scale (VFS), which is subjective, and the performance-based fatigue test (aPVT). This exploration is crucial for improving clinical applicability.

研究设计

研究类型
Observational

入排标准

年龄范围
35.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Degree of hearing loss: from normal up to moderate hearing loss Native Kannada speakers with at least 12th standard education.
  • Individuals who score above 26 on the MoCA rating.

排除标准

  • Suffering from a chronic condition that can cause fatigue.
  • Individuals with an intake of fatigue-inducing drugs/undergoing interventions that induce fatigue.
  • Conductive or Mixed hearing losses.
  • Diagnosed with conditions that affect cognition negatively.

结局指标

主要结局

1) aPVT -Objective listening-related fatigue score.

时间窗: Baseline

2) Vanderbilt Fatigue Scale (Kannada version) -Subjective listening-related fatigue score.

时间窗: Baseline

次要结局

未报告次要终点

研究者

发起方
Diya Deepak
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Diya Deepak

Manipal College of Health Professions

研究点 (1)

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