| CTRI Number |
CTRI/2023/12/060683 [Registered on: 22/12/2023] Trial Registered Prospectively |
| Last Modified On: |
20/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Earphone use and its effect on hearing acuity |
|
Scientific Title of Study
|
A Study of hearing acuity and health of external auditory canal in earphone users |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ayushi Ghoshmoulic |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept.of ENT Acharya Vinoba Bhave Rural Hospital Jawaharlal Nehru Medical College Sawangi
Wardha MAHARASHTRA 442001 India |
| Phone |
9970056865 |
| Fax |
|
| Email |
ayushighoshmoulic345@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Prasad Deshmukh |
| Designation |
Professor and Head of Department |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept.of ENT Acharya Vinoba Bhave Rural Hospital Jawaharlal Nehru Medical College Sawangi
Wardha MAHARASHTRA 442001 India |
| Phone |
9765404133 |
| Fax |
|
| Email |
hod.entjnmc@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Prasad Deshmukh |
| Designation |
Professor and Head of Department |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept.of ENT Acharya Vinoba Bhave Rural Hospital Jawaharlal Nehru Medical College Sawangi
MAHARASHTRA 442001 India |
| Phone |
9765404133 |
| Fax |
|
| Email |
hod.entjnmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi(Meghe)Wardha |
| 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 Ayushi Ghoshmoulic |
Department of ENT, Jawaharlal Nehru Medical College |
Datta Meghe Institute of Higher Education and Research
Sawangi (Meghe), Wardha Wardha MAHARASHTRA |
9970056865
ayushighoshmoulic345@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute Of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H833||Noise effects on inner ear, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients between the age group of 15-35 years of age
Any gender
2. Patients with use of earphones for both professional and personal uses.
3. Patients with otomycosis, otalgia,impacted wax ,tinnitus and reduced hearing
|
|
| ExclusionCriteria |
| Details |
1. Patients with congenital SNHL, occupational NIHL
2. Patients with a known immunodeficiency disorder, hypertension
3. Patients with perforation of the tympanic membrane, com, and other causes of hearing loss
4. Patients with a granulomatous disorder of temporal bone and vertigo
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| THIS STUDY CONDUCTED BETWEEN THE AGE GROUPS OF 15-35 WILL BE DONE TO COMPARE THE HEARING BETWEEN EARPHONE USERS AND NON USERS AND ESTABLISH A PROTOCOL TO MAINTAIN HEALTHY EAC AND PROPER EAR PHONE USAGE TO PREVENT EARLY HEARING LOSS |
BASELINE |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="130" Sample Size from India="130"
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)
|
30/12/2023 |
| 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="2" 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
|
Noise-induced
hearing loss as seen in today’s young generation is primarily due to
long-duration exposure to personal listening devices like earphones,
headphones, earbuds, and other different types of personal listening devices.
With the rise in internet usage, online education as well as online gaming, the
use of personal listening devices has increased fourfold. The exposure to noise
above 85 dB for a long duration is the most common cause of reduced hearing
acuity. Normally the earphones and headphones tend to produce the volume of 78
to 136 dB. Hence continuous exposure to such amplitudes may cause hearing loss
especially in adolescents. However the new feature of noise cancellation in
earphones and headphones is said to reduce the cases of noise induced hearing
loss by decreasing the ambient noises, thus leading to better hearing in low
volumes even in crowded or noisy places. It is also seen that with continuous
usage of earphones there are increased incidences of otomycosis and increased
cerumen production as well. This study aims to establish a relationship between
hearing loss and affects on health of external auditory canal in earphone users
if any. |