| CTRI Number |
CTRI/2024/03/064451 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To check hearing status using mobile app |
|
Scientific Title of Study
|
Evaluation of hearing status using the hearWHOpro |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shreeka Prakash |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Room No 1, Department of Community Medicine, Biochemistry Building, Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9148865610 |
| Fax |
|
| Email |
shreeka.kmcmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Chythra R Rao |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Room No 1, Department of Community Medicine, Biochemistry Building, Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448857793 |
| Fax |
|
| Email |
chythra.raj@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Chythra R Rao |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Room No 1, Department of Community Medicine, Biochemistry Building, Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448857793 |
| Fax |
|
| Email |
chythra.raj@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal- Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Shreeka Prakash |
| Address |
Kasturba Medical College Tiger Circle Road, Madhav Nagar, Manipal |
| 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 Shreeka Prakash |
Kasturba Medical College, Manipal |
Room No 1, Department of Community Medicine, 3rd floor, Biochemistry building, KMC, Manipal, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
9148865610
shreeka.kmcmpl2022@learner.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 |
| Healthy Human Volunteers |
Screening to check hearing status |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Individuals residing in rural communities/visiting health centers in
Udupi above 18 years who give a written informed consent |
|
| ExclusionCriteria |
| Details |
Participants with
documented hearing loss, unable to comprehend/respond to questionnaire/tool |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| prevalence of hearing loss |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="736"
Sample Size from India="736"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="734" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2024 |
| Date of Study Completion (India) |
01/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
Hearing loss is a prevalent issue in India, affecting both children and adults. The prevalence of hearing impairment in neonates ranges from 1.59 to 8.8 per 1000 births, with higher rates among ’at risk’ neonates [1]. In children, the prevalence of hearing loss ranges from 6.6% to 16.47% [2]. It is estimated that about 15% of students in India have transient hearing loss, which can impact their educational achievement [3] . Community-based studies have reported a prevalence of hearing loss between 6% and 26.9%, with higher rates in rural areas and among the elderly [4] . Early detection of hearing loss is crucial for its effective management especially for those who often listen to loud music, work in noisy places, use medicines that are harmful to hearing and are above 60 years old. Therefore, hearing impairment remains a significant public health concern in India and there is a need for early detection and intervention programs to address the issue. |