| 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
|
|
|
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
|
|
|
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. |