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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  
Name  Address 
nil  na 
 
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  
Status 
Not Applicable 
 
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  
Outcome  TimePoints 
na   na 
 
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.

 
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