FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/091801 [Registered on: 27/07/2025] Trial Registered Prospectively
Last Modified On: 26/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   The connection between how tired adults feel after listening and how that tiredness affects their performance in listening tasks. 
Scientific Title of Study   Relationship between subjective and objective Listening-related fatigue in 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  Diya Deepak 
Designation  Post Graduate student pursuing MSc in Audiology 
Affiliation  Manipal College of Health Professions 
Address  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi, Karnataka, 576104

Udupi
KARNATAKA
576104
India 
Phone  6282626573  
Fax    
Email  diya5.mchpmpl2024@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, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi, 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, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi, Karnataka, 576104

Udupi
KARNATAKA
576104
India 
Phone  9886135522  
Fax    
Email  hari.prakash@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, India, Pin: 576104  
 
Primary Sponsor  
Name  Diya Deepak 
Address  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi, Karnataka, 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 P   Kasturba Hospital  Research Lab, Department of Speech and Hearing, Baliga Block, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi, 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 2   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Middle aged adults from 35 to 55 years with no hearing impairment. 
Patients  (1) ICD-10 Condition: H838||Other specified diseases of innerear,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Degree of hearing loss: from normal up to moderate hearing loss
Native Kannada speakers with at least 12th standard education.
Individuals who score above 26 on the MoCA rating.

 
 
ExclusionCriteria 
Details  Suffering from a chronic condition that can cause fatigue.
Individuals with an intake of fatigue-inducing drugs/undergoing interventions that induce fatigue.
Conductive or Mixed hearing losses.
Diagnosed with conditions that affect cognition negatively.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) aPVT -Objective listening-related fatigue score.
2) Vanderbilt Fatigue Scale (Kannada version) -Subjective listening-related fatigue score. 
Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/08/2025 
Date of Study Completion (India) 25/04/2026 
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  

Listening-related fatigue is associated with a sustained effort given to a task involving listening and can be measured both subjectively and objectively. Initially Institutional Research Committee, MCHP approval would be taken followed by the Institutional Ethics Committee, KH Manipal approval, and Registration in Clinical Trial Registry- India. Participants will be recruited from outpatients in the Department of Speech and Hearing at KMC Hospital and individuals in and around the hospital, who are willing to participate, based on their availability. The study will include an explanation of the procedures and the collection of informed consent. Potential participants will be screened according to the established inclusion and exclusion criteria. Patients who pass the audiometric screening and Montreal Cognitive Assessment (MoCA ®) will undergo the administration of the VFS in its Kannada version. Further, the aPVT test will be administered using E-Prime software on a laptop running Windows 11.

Aim and Objective: To explore the relationship between subjective and objective Listening-related fatigue in adults.

Justification of the study: This study may help bridge the gap or understanding between self-reported and objective performance measures, guiding us to understand fatigue better. Listening-related fatigue is primarily a subjective experience, and current assessments rely exclusively on subjective tools. To better understand the various dimensions of fatigue, it is essential to explore the correlation between the Voice Fatigue Scale (VFS), which is subjective, and the performance-based fatigue test (aPVT). This exploration is crucial for improving clinical applicability.

 
Close