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临床试验/CTRI/2024/09/073327
CTRI/2024/09/073327已完成不适用

To Evaluate Speech in Noise Permormance Among Middle-Aged Adults

Pavithra1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2024年9月20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
76
试验地点
1
主要终点
1. Spatial Separation Sentence Test-Kannada -SNR in dB

研究概览

简要总结

Project Title

Exploration of Speech-in-Noise Performance Among Middle-Aged Adults

Type of Study

Prospective Cross-Sectional Study

Aims & Objectives

To investigate the perception of speech in noise among individuals aged 40 to 60 years.

Justification for Study

This study addresses the early decline in speech-in-noise (SPIN) performance, which can begin in middle age. There is a scarcity of research exploring the relationship between SPIN perception, age, hearing status, and cognitive status in middle-aged individuals. This study aims to bridge this gap.

Departments Involved

Department of Speech and Hearing, Manipal College of Health Professions (MCHP), Manipal Academy of Higher Education (MAHE), Manipal

Study Period

IRC approval: 1 month

IEC review and approval: 1-2 months

CTRI registration: 2 months

Data collection: June 2024 - February 2025

Data analysis and manuscript submission: March 2025

 Sample Size

The study requires a total of 76 participants, divided into two groups of 38 each. This sample size is calculated to achieve 80% power with a significance level of 5%, considering a 15% margin of error.

Materials and Methods

Inclusion Criteria

Age between 40 to 60 years

Both genders in equal proportion

Native Kannada speakers

Hearing loss less than 25 dBnHL

 Exclusion Criteria

Pre-existing neurological and psychological conditions

Medical conditions such as hypertension, diabetes mellitus, cardiovascular disease, etc.

Statistical Methods

Data will be entered into an Excel spreadsheet and analyzed using IBM SPSS/JAMOVI software.

Normal distribution will be checked using visual methods (histograms) and analytical techniques (Shapiro-Wilk test).

Regression analysis will estimate changes in SPIN scores with age.

MoCA, GPAQ, NESI, and PHQ-9 scores will be adjusted stepwise, and results interpreted accordingly.

 Tools Used

Montreal Cognitive Assessment (MoCA)

Noise Exposure Standard Interview (NESI)

Global Physical Activity Questionnaire (GPAQ)

Patient Health Questionnaire-9 (PHQ-9)

 Detailed Description of Procedure / Processes

Ethical approvals will be obtained from the Institutional Research Committee (IRC) and Institutional Ethics Committee (IEC) at MAHE, and the study will be registered with the Clinical Trials Registry - India (CTRI).

Eligible individuals will be approached, and the study will be explained in detail. Written consent will be obtained from participants.

Participants will complete the MoCA, GPAQ, PHQ-9, and NESI questionnaires.

The Spatial Separation Sentence Test – Kannada will be administered using MATLAB (R2022b) in a noise-free household setting. Participants will listen to 30 Kannada sentences with distractor noise presented at 0°, +90°, and -90° azimuths through headphones and repeat the sentences. The signal-to-noise ratio (SNR) level will be determined using a 50% response criterion or when participants achieve at least two correct responses out of three.

 Outcome Measures

Auditory Processing Abilities: Measured using the Spatial Separation Sentence Test-Kannada, expressed as SNR in dB.

Cognitive Skills: Assessed using the Montreal Cognitive Assessment, scored out of 30.

Physical Activity: Measured using the Global Physical Activity Questionnaire, expressed as MET minutes per activity.

Depression: Assessed using the Patient Health Questionnaire-9, scored out of 27.

Noise Exposure: Measured using the Noise Exposure Standard Interview questionnaire, measured as a cumulative noise exposure score.

 Potential Risks and Benefits

 Risks

Minimal risks including mental exhaustion and time commitment required to complete all tests.

Benefits

Identifying the age range for the decline in auditory processing abilities can aid in more accurate clinical diagnosis and treatment.

Ethical Considerations

Clearances from IEC and IRC will be obtained along with CTRI approval.

If permission is required to use the questionnaires, it will be secured from the authors.

Detailed explanations will be provided to participants, and written consent will be obtained.

Study records will be kept confidential and reviewed only by authorized personnel. Data will not be shared without written permission from participants.

 Budget and Funding

Not applicable.

Review of Literature

Existing studies on speech perception primarily focus on individuals aged 60 and older, with limited research on the 40 to 60 age group. This critical transitional period raises questions about the early onset of speech perception difficulties and contributing factors. Most studies utilize electrophysiological measures with limitations such as small sample sizes. While these measures help understand neural processing, they may not fully capture the complexities of speech perception in adverse listening conditions. Therefore, a comprehensive approach, including behavioral assessments, is necessary to better understand the speech in noise challenges and associated cognitive factors in middle-aged individuals.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • 1 Individuals aged between 40 to 60 years 2 Both genders in equal proportions 3 Native Kannada speakers 4 Hearing loss less than 25dBHL.

排除标准

  • 1 Individuals with pre-existing neurological and psychological conditions 2 Any medical conditions like hypertension, diabetes mellitus, cardiovascular disease, etc.

结局指标

主要结局

1. Spatial Separation Sentence Test-Kannada -SNR in dB

时间窗: The study outcomes will be assessed in a single time point as it is an observational study.

2. Montreal Cognitive Assessment Tool - Scores

时间窗: The study outcomes will be assessed in a single time point as it is an observational study.

3. Patient Health Questionnaire-9 - Scores

时间窗: The study outcomes will be assessed in a single time point as it is an observational study.

4. Global Physical Activity Questionnaire - MET minutes per activity

时间窗: The study outcomes will be assessed in a single time point as it is an observational study.

5. Noise Exposure Standard Interview - cumulative lifetime noise exposure

时间窗: The study outcomes will be assessed in a single time point as it is an observational study.

次要结局

未报告次要终点

研究者

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

Pavithra

Manipal Academy of Higher Education

研究点 (1)

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