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CTRI Number  CTRI/2024/09/073327 [Registered on: 04/09/2024] Trial Registered Prospectively
Last Modified On: 24/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To evaluate adults ability to perceive speech in noise 
Scientific Title of Study   To Evaluate Speech in Noise Permormance Among Middle-Aged Adults 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pavithra 
Designation  Post graduate student 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8618279575  
Fax    
Email  pavithra.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Hari Prakash 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9886135522  
Fax    
Email  hari.prakash@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Hari Prakash 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9886135522  
Fax    
Email  hari.prakash@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Health Professions (MCHP) Manipal Academy of Higher Education 
 
Primary Sponsor  
Name  Pavithra 
Address  Department of Speech and Hearing Manipal College of Health Professions (MCHP) Manipal Academy of Higher Education Manipal Karnataka India 576104 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hari Prakash  Community based  Udupi Karnataka India
Udupi
KARNATAKA 		 9886135522

hari.prakash@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KMC and KH Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy participants with the age range of 40 to 60 years 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Individuals aged between 40 to 60 years
2 Both genders in equal proportions
3 Native Kannada speakers
4 Hearing loss less than 25dBHL 
 
ExclusionCriteria 
Details  1 Individuals with pre-existing neurological and psychological conditions
2 Any medical conditions like hypertension, diabetes mellitus, cardiovascular disease, etc. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Spatial Separation Sentence Test-Kannada -SNR in dB
2. Montreal Cognitive Assessment Tool - Scores
3. Patient Health Questionnaire-9 - Scores
4. Global Physical Activity Questionnaire - MET minutes per activity
5. Noise Exposure Standard Interview - cumulative lifetime noise exposure 		 The study outcomes will be assessed in a single time point as it is an observational study. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
Final Enrollment numbers achieved (Total)= "76"
Final Enrollment numbers achieved (India)="76" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/09/2024 
Date of Study Completion (India) 17/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.


 
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