| CTRI Number |
CTRI/2025/10/095874 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
10/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Creating an Auditory Training Program on a Mobile App to help improve the Listening Skills of Older People using Hearing Aids |
|
Scientific Title of Study
|
Development and Usability Assessment of a Mobile App-Based Auditory Training Program to Enhance Auditory Cognitive Processing for Hearing Aid Users with Age-related Hearing Loss |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Srishti Munjal |
| 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 |
7087878344 |
| Fax |
|
| Email |
srishti2.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hari Prakash P |
| Designation |
Additional 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 |
Additional Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing, Manipal College of Health Professions, MAHE, Manipal, Karnataka - 576104
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
|
|
|
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
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Amplification |
The group will receive amplification alone for 3 weeks duration. Post evaluation will be carried out after 3 weeks and compared with the intervention group. |
| Intervention |
Amplification with Auditory training |
The intervention group will receive 3 weeks (20 mins X 2-3 days a week) of comprehensive
auditory-cognitive training on their own device at home. Participants will be asked to undergo training at their most comfortable level (MCL). They will undergo training under two modules
based on the developed module in Phase 1 of the study. It will include an auditory-cognition module and an augmentative
strategies module. During this time, finetuning or a change in the hearing aid
program will not be done.
Post-training assessments will be done immediately after
intervention (T1) and at one-month follow-up (T2), to evaluate barriers and facilitators of app usage and
user experience. For post-training assessment (T1) and follow-up training assessment (T2),
participants will visit the Department of Speech and Hearing, Kasturba Hospital. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Phase 1A:
Listening needs assessment: Older adults (60-80 years) who are Hearing aid users with greater than or equal to 1 year of consistent use, more than 6 hours per day
COSI validation: Participants (age 18-80 yrs), Hearing aid users greater than or equal to 6 hours per day)
Phase 1B:
Expert validation: Experts with a minimum of 5 years of experience in auditory training or hearing aid fitting and research
Participant feedback: Individuals who are within the range of 60-80 years. Participants must have a hearing loss greater than 55 dB hearing level (HL)
Phase 2:
The age range of the participants will be 60-80 years (males and females), and they primarily
use the Kannada language. Participants should have completed the 12th standard. Participants should have SNHL (Sensorineural Hearing loss), PTA greater than or equal to 55 dBHL.Participants should be novice hearing aid users.Participants should know how to use a smartphone using the Mobile Device Proficiency Questionnaire (MDPQ-16). |
|
| ExclusionCriteria |
| Details |
Phase 1B:
Participant feedback:
Self-reported neurological conditions such as Parkinson’s disease, dementia, or a history of
stroke, alongside psychological impairments including anxiety and depression. Participants who are unfamiliar with the use of mobile phones.
Phase 2:
Participants with past or present history of middle ear surgery. Any history of neurological disorders (epilepsy, stroke, etc.). Uncontrolled systemic problems like diabetes and blood pressure
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study addresses the listening needs of hearing aid users.
This study aims to develop a validated training module for hearing rehabilitation interventions.
The study will provide evidence-based feasibility metrics, identify barriers to implementation, and assess the practicality of future randomized controlled trials.
It provides evidence supporting auditory training as a complementary treatment option. |
0 weeks
3 weeks
7 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="230"
Sample Size from India="230"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/11/2025 |
| 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 Yet Recruiting |
| 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, validate, and assess the feasibility of a mobile-based auditory-cognitive training program for hearing aid users with age-related hearing loss (ARHL). Its objectives include creating and validating an auditory-cognitive training module, implementing it on a mobile app platform, and evaluating its effectiveness in improving auditory and cognitive functions. |