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临床试验/CTRI/2024/09/073679
CTRI/2024/09/073679已完成不适用

Central auditory processing abilities in Type 2 Diabetes Mellitus - An exploratory study

Els Marry Suresh1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年9月25日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
试验地点
1
主要终点
The auditory processing abilities are measured as scores for DDT, ATTR and PPT

研究概览

简要总结

1. Title: Central Auditory Processing Abilities in Type II Diabetes Mellitus – An Exploratory Study

2. Type of Study: Prospective, cross-sectional study

3. Aims & Objectives

Primary Objective: Explore and compare auditory processing abilities in individuals with Type 2 Diabetes Mellitus (T2DM) and without diabetes.

Secondary Objective: Investigate the relationship between auditory processing, cognitive abilities, and lifestyle (noise exposure) in T2DM patients.

4. Justification: Existing studies by Workman et al. (2017) and Pirasteh et al. (2018) indicate deterioration in auditory processing abilities among individuals with T2DM, but comprehensive understanding is lacking. This study aims to bridge this gap, highlighting how cognitive impairments associated with T2DM affect auditory processing, essential for better management strategies.

5. Departments Involved:

  • Center for Podiatry & Diabetic Foot Care & Research, MAHE
  • Department of Speech and Hearing, MCHP, MAHE

6. Study Period:

  • Reviews and approvals: 2-3 months
  • Data collection: June 2024 – February 2025
  • Analysis and manuscript submission: March 2025

7. Sample Size:

  • Total: 62 participants (31 T2DM, 31 control)
  • Calculated using power study and significance level parameters from Mishra et al. (2016)

8. Materials and Methods:

  • Inclusion Criteria:

  • T2DM Group: Aged 45-60, native Kannada speakers, mild hearing loss, minimum 2 years T2DM duration, HBA1c > 6.5%

  • Control Group: Aged 45-60, native Kannada speakers, mild hearing loss, no diabetes

  • Exclusion Criteria:

  • T2DM Group: Neuropathies, hypertension, early dementia, ototoxic drug intake, treatment with insulin/oral hypoglycemic agents

  • Control Group: Hypertension, early dementia, ototoxic drug intake

  • Statistical Methods:

  • Data analysis using SPSS or Jamovi

  • T-tests, correlation analysis, MANOVA to compare auditory processing tests controlling for age, noise exposure, and cognitive ability

  • Tools:

  • Noise Exposure Questionnaire (NEQ) by Tiffany et al. (2017)

  • Montreal Cognitive Assessment (MoCA) by Nasreddine et al. (2005)

9. Procedure: Participants will be recruited from specified centers, screened based on criteria, and undergo auditory processing tests (SPIN, ATTR, PPT, DDT). NEQ and MoCA questionnaires will assess noise exposure and cognitive abilities for the T2DM group. The entire procedure will last 45 minutes to 1 hour, with breaks as needed. Data will be analyzed to compare performances between T2DM and control groups.

10. Outcome Measures:

  • Scores for DDT, ATTR, PPT
  • SNR loss for SPIN test
  • Noise exposure and cognitive decline scores from questionnaires

11. Risks and Benefits:

  • Risks: Minimal, primarily discomfort due to the procedure duration
  • Benefits: Participants receive information on auditory processing, cognition, and hearing levels, contributing to better understanding and management strategies

12. Ethical Considerations:

  • Clearances from IEC, IRC, and CTRI
  • Informed consent obtained from participants
  • Confidentiality maintained
  • Data reviewed only by authorized personnel

13. Budget and Funding: Not applicable

14. Literature Review:

Research indicates a higher likelihood of hearing loss and cognitive impairments among T2DM individuals, affecting their quality of life

Studies by Mishra et al. (2016), Yaffe et al. (2020), Srikanth et al. (2020), and Moheet et al. (2015) show poor performance in temporal resolution tasks and other cognitive domains among diabetic patients.

This study aims to fill the research gap by considering multiple covariant factors together, enhancing understanding of the complex interactions between T2DM and auditory processing.

研究设计

研究类型
Observational

入排标准

年龄范围
45.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • T2DM Age of 45 to 60 years Native Kannada speakers with at least 12th standard education Hearing loss less than Mild degree (less than 25dBHL) for Puretone averages of 500Hz 1kHz and 2kHz Duration of T2DM of minimum 2 years Individuals with T2DM having HBA1c levels greater than 6.5percentage Individuals with and without medication for T2DM Group
  • normal individuals Age of 45 to 60 years Native Kannada speakers with at least 12th standard education Hearing loss less than Mild degree (less than 25dBHL) for Puretone averages of 500Hz 1kHz and 2kHz. Individuals with no diabetes mellitus (self reported).

排除标准

  • T2DM Associated neuropathies (reports) Hypertension (self reported /reports) Early dementia (self reported/reports) Individuals with intake of ototoxic drugs (Example:cisplatin, loop diuretics) Treatment with insulin and oral hypoglycemic agents Group
  • normal individuals Hypertension (self reported) Early dementia (self reported) Individuals with intake of ototoxic drugs (Example:cisplatin, loop diuretics).

结局指标

主要结局

The auditory processing abilities are measured as scores for DDT, ATTR and PPT

时间窗: The above mentioned tests will be done at a single time point

The SPIN test is measured as SNR loss

时间窗: The above mentioned tests will be done at a single time point

The questionnaires administered on diabetes individuals provide an outcome measure of annual noise exposure and cognitive decline in scores

时间窗: The above mentioned tests will be done at a single time point

次要结局

未报告次要终点

研究者

发起方
Els Marry Suresh
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Els Marry Suresh

Manipal College of Health Professions

研究点 (1)

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