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CTRI Number  CTRI/2025/03/082719 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 11/03/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Measuring Listening Effort in Kannada Speakers: Creating a New Assessment Tool for adults 
Scientific Title of Study   Development and Validation of Behavioural Measure of Listening Effort for Adults in Kannada 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhavana R 
Designation  PhD Scholar 
Affiliation  Manipal College of Health Professions 
Address  Department of Speech and Hearing, Manipal College of Health Professions, MAHE, Manipal, Karnataka - 576104

Udupi
KARNATAKA
576104
India 
Phone  8921861885  
Fax    
Email  bhavana.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Hari Prakash P 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Speech and Hearing, Manipal College of Health Professions, MAHE, Manipal, Karnataka - 576104

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

Udupi
KARNATAKA
576104
India 
Phone  9886135522  
Fax    
Email  hari.prakash@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College and Hospital, Manipal Academy of Higher Education, Manipal, Karnataka, India,576104  
 
Primary Sponsor  
Name  KMC Manipal 
Address  Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India,576104 
Type of Sponsor  Private medical college 
 
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 P  Kasturba Medical Hospital   Dept of Speech and Hearing, Kasturba Medical College , Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104 Udupi KARNATAKA
Udupi
KARNATAKA 		 9886135522

hari.prakash@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College And Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal Hearing Healthy Adults (18-60 years) 
Patients  (1) ICD-10 Condition: H839||Unspecified disease of inner ear,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Controls(Normal hearing individuals)  The study will be conducted at: Kasturba Medical College and Hospital, Department of Speech and Hearing (Room No 27). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  Aged 18 to 59 years

Normal hearing (thresholds better than 25 dB HL)

have normal middle ear functioning.

Hearing Impaired Group:Hearing sensitivity better than 25 dB HL up to severe hearing loss (up to 70 dB HL)

Primary language is Kannada

MoCA score of at least 26

Individuals should have at least an 8th grade level of education.

Normal vision or corrected vision
 
 
ExclusionCriteria 
Details  History of sensory deficits (including vision and Hearing)

Any neurological conditions & psychological illness
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Phase 1: WIRT Development and Validation
Accuracy: Percentage of correctly identified words in the WIRT.
Reaction Time: Speed of response to auditory stimuli (ms).
Item Difficulty: Performance metrics to refine word difficulty levels.
Phase 2: Translation and Validation of Behavioral Measures
Listening Effort: Self-reported scores on a 10-question Visual Analog Scale (VAS).
Translation Accuracy: Accuracy in translating the EEAS questionnaire.
Internal Consistency: Reliability of the EEAS (Cronbach’s alpha).
Phase 3: Normative Estimation and Validation
Normative Baselines: WIRT performance data from 200 participants.
Group Comparisons: Differences in WIRT performance and listening effort between normal-hearing and hearing-impaired groups (27 participants each). 		 Phase 1: WIRT Development and Validation
Accuracy: Percentage of correctly identified words in the WIRT.
Reaction Time: Speed of response to auditory stimuli (ms).
Item Difficulty: Performance metrics to refine word difficulty levels.
Phase 2: Translation and Validation of Behavioral Measures
Listening Effort: Self-reported scores on a 10-question Visual Analog Scale (VAS).
Translation Accuracy: Accuracy in translating the EEAS questionnaire.
Internal Consistency: Reliability of the EEAS (Cronbach’s alpha).
Phase 3: Normative Estimation and Validation
Normative Baselines: WIRT performance data from 200 participants.
Group Comparisons: Differences in WIRT performance and listening effort between normal-hearing and hearing-impaired groups (27 participants each). 
 
Secondary Outcome  
Outcome  TimePoints 
1. Assess differences in listening effort between hearing-impaired participants & normal-hearing participants using the Word Identification & Recall Test (WIRT) & Extended Effort Assessment Scale (EEAS).
2.Investigate electrophysiological markers during the WIRT task in normal-hearing participants.
3.Investigate electrophysiological markers (e.g., amplitude & latency) during the WIRT task in normal-hearing participants. 		 Measured at baseline & at post-assessment (e.g., 4 weeks & 8 weeks) for group comparisons.
Electrophysiological markers recorded during WIRT sessions at specified time points (e.g., baseline & follow-ups). 
 
Target Sample Size   Total Sample Size="369"
Sample Size from India="369" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   The study aims to develop and validate behavioural and self-reported listening effort measures tailored for Kannada-speaking adults. It involves the creation of a novel Word Identification and Recall Test (WIRT) and the translation and validation of the Extended Effort Assessment Scale (EEAS) into Kannada. The study also aims to establish normative baselines and evaluate these tools among normal-hearing and hearing-impaired populations.Listening effort can be reliably measured and validated in Kannada-speaking adults through behavioural paradigms like the WIRT and self-reported measures like the EEAS, enabling improved clinical assessment of listening effort in hearing-impaired individuals. 
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