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临床试验/CTRI/2025/10/095874
CTRI/2025/10/095874尚未招募2 期

Development and Usability Assessment of a Mobile App-Based Auditory Training Program to Enhance Auditory Cognitive Processing for Hearing Aid Users with Age-related Hearing Loss

KMC Manipal1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2025年11月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
230
试验地点
1
主要终点
This study addresses the listening needs of hearing aid users.

研究概览

简要总结

The study aims to develop, validate, and assess the feasibility of a mobile-based auditory-cognitive training program for hearing aid users with age-related hearing loss (ARHL). Its objectives include creating and validating an auditory-cognitive training module, implementing it on a mobile app platform, and evaluating its effectiveness in improving auditory and cognitive functions.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Phase 1A: Listening needs assessment: Older adults (60-80 years) who are Hearing aid users with greater than or equal to 1 year of consistent use, more than 6 hours per day COSI validation: Participants (age 18-80 yrs), Hearing aid users greater than or equal to 6 hours per day) Phase 1B: Expert validation: Experts with a minimum of 5 years of experience in auditory training or hearing aid fitting and research Participant feedback: Individuals who are within the range of 60-80 years.
  • Participants must have a hearing loss greater than 55 dB hearing level (HL) Phase 2: The age range of the participants will be 60-80 years (males and females), and they primarily use the Kannada language.
  • Participants should have completed the 12th standard.
  • Participants should have SNHL (Sensorineural Hearing loss), PTA greater than or equal to 55 dBHL.Participants should be novice hearing aid users.Participants should know how to use a smartphone using the Mobile Device Proficiency Questionnaire (MDPQ-16).

排除标准

  • Phase 1B: Participant feedback: Self-reported neurological conditions such as Parkinson’s disease, dementia, or a history of stroke, alongside psychological impairments including anxiety and depression.
  • Participants who are unfamiliar with the use of mobile phones.
  • Phase 2: Participants with past or present history of middle ear surgery.
  • Any history of neurological disorders (epilepsy, stroke, etc.).
  • Uncontrolled systemic problems like diabetes and blood pressure.

结局指标

主要结局

This study addresses the listening needs of hearing aid users.

时间窗: 0 weeks | 3 weeks | 7 weeks

This study aims to develop a validated training module for hearing rehabilitation interventions.

时间窗: 0 weeks | 3 weeks | 7 weeks

The study will provide evidence-based feasibility metrics, identify barriers to implementation, and assess the practicality of future randomized controlled trials.

时间窗: 0 weeks | 3 weeks | 7 weeks

It provides evidence supporting auditory training as a complementary treatment option.

时间窗: 0 weeks | 3 weeks | 7 weeks

次要结局

未报告次要终点

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

Srishti Munjal

Manipal College of Health Professions

研究点 (1)

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