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CTRI Number  CTRI/2021/02/031143 [Registered on: 09/02/2021] Trial Registered Prospectively
Last Modified On: 09/10/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Effect of regular noise exposure on the balance function of the inner ear and the burden of balance dysfunction due to regular noise exposure among the traffic police personnel and automobile drivers. 
Scientific Title of Study   Effect of chronic noise exposure on the vestibular function and the burden of vestibular dysfunction due to chronic noise exposure among the traffic police personnel and automobile drivers. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Soumyajit Das 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Mangalagiri 
Address  Department of ENT, OPD Block, 1st Floor All India Institute of Medical Sciences, Mangalagiri, Old TB Sanatorium Road;

Guntur
ANDHRA PRADESH
522503
India 
Phone  9864371311  
Fax    
Email  drsoumya_entamch@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Soumyajit Das 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Mangalagiri 
Address  Department of ENT, OPD Block, 1st Floor All India Institute of Medical Sciences, Mangalagiri, Old TB Sanatorium Road;

Guntur
ANDHRA PRADESH
522503
India 
Phone  9864371311  
Fax    
Email  drsoumya_entamch@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Soumyajit Das 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Mangalagiri 
Address  Department of ENT, OPD Block, 1st Floor All India Institute of Medical Sciences, Mangalagiri, Old TB Sanatorium Road;

Guntur
ANDHRA PRADESH
522503
India 
Phone  9864371311  
Fax    
Email  drsoumya_entamch@rediffmail.com  
 
Source of Monetary or Material Support  
Department of Health Research/Indian Council of Medical Research, New Delhi 
 
Primary Sponsor  
Name  DHR ICMR 
Address  V. Ramalingaswamy Bhawan, P.O.Box No 4911, Ansari Nagar, New Delhi - 110029 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSoumyajit Das  All India Institute of Medical Sciences, Mangalagiri  Department of ENT, OPD Block, 1st Floor, Room 119 All India Institute of Medical Sciences, Mangalagiri Old TB Sanatorium Road;
Guntur
ANDHRA PRADESH 
9864371311

drsoumya_entamch@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC,AIIMS,Mangalagiri  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Vestibular function 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Exposed group:
1.All individuals within 25 -50 years of age
group
2.Traffic policemen and automobile drivers
working in a noisy environment for atleast
5 hours per day for the last 5 years or
more.
3.No history of any vestibular crisis in
the past.
4.Persons willing to undergo complete
vestibular evaluation tests.

For Non exposed group:
1.Healthy volunteers within 25 – 50 years age
2.Not exposed to any form of acute or
chronic noise exposure
 
 
ExclusionCriteria 
Details  1.Non consent
2.Known case of anemia, diabetes, hypertension,
hypothyroidism ,cardiac ailment and or
chronic kidney disease.
3.Known case of vestibular dysfunction
4.Individuals with history of Tullio
phenomenon in the past.
5.Known case of Psychiatric disorders
6.Persons who have taken vestibular
suppressant medications.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Vestibular functions  at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Burden of vestibular dysfunction in noise exposed  at baseline 
 
Target Sample Size   Total Sample Size="242"
Sample Size from India="242" 
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)   15/02/2021 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Introduction:

Noise  pollution  is  an  important  health  hazard  and  affects  the  hearing  threshold  in  chronic  exposure. There  are  various  non-auditory  effects  of  chronic  noise  exposure  which  can  affect  the  cardiovascular  system, sleep  pattern  and  cognitive  function (Basner, et al. 2014).  The  balance  system  though  functionally  independent  from  the  auditory  system  is  intricately  embedded  within  the  bony  labyrinth  of  the  inner  ear  and  has  complex  neural  network  that  connect  the  peripheral  receptors  with  the  higher  centres. The  saccule  which  is  a  part  of  the  balance  system has  been  found  to  respond  to  sound  and  plays  a  key  role  in  the  equilibrium. There  are  concerns  that  chronic  noise  exposure  can  affect the  vestibular  system.  Traffic  policemen  and  automobile  drivers  are  exposed  to  high  noise  levels.  Unlike  industrial  workers  where  there  are  regulations  on  the  safe  noise  levels  and  usage  of  noise  prevention  strategies,  traffic  policemen  and  automobile  workers  are  exposed  to  unregulated  levels  of  noise  exposure  during  their  daily  activities.  Further  the  effect  of  noise  in  the  vestibular  function  on  these  group  has  not  been  studied.  Vestibular  dysfunction  if  any  in  these  group  can  be  dangerous  and  have  widespread  implications  in  the  routine  performance  of  daily  activities.  Hence  the  need  for  this  present  study.  

Research Question

1 Does noise exposure affect the vestibular function? 

2. What is the burden of the vestibular dysfunction due to chronic noise exposure?

The  aims  and  objectives  of  the  study  are:

  • 1.     To compare  the  vestibular function between noise exposed and controls by estimating the  latency and amplitude of the Vestibular evoked myogenic potentials ( VEMP)
  • 2.     To determine the  effect of  chronic  noise exposure  on  dynamic  posturography.
  • 3.     To determine  the  effect  of  chronic  noise  exposure  on  the  caloric function during videonystagmography (VNG)
  • 4.     To  determine  the  effect  of  chronic  noise  exposure  on  the  vestibulo-ocular  reflex (VOR).
  • 5.     To  estimate  the  burden  of  vestibular  dysfunction  due  to  chronic  noise  exposure  among  the  study  group.


Expected  outcome  of  the  study:

  • 1.     We  will  be  able  to  find  out  whether  chronic noise  exposure  has  any  effect  on  the  vestibular  system.
  • 2.     We  will  be  able  to  identify   the  noise  level ,  and  the  duration  of  exposure  at  which  such  changes  take  place.
  • 3.     There  can  be  far reaching  effect   in  regularizing  the  safe  level  of  noise  at  workplace.
  • 4.     It  will  be  possible  to  take  preventive  measures to  prevent  noise induced vestibular dysfunction.
  • 5.     We  will  be  able  to  estimate  the  burden  of  vestibular dysfunction in chronic noise exposure.

Novelty:

The  effect  of  noise  exposure  on  the  auditory  system  is  well  documented.  However  the  long  term  effect  of  the  noise  exposure  on  the  vestibular  system  is  not  conclusive  and  most  of  the  studies  have   evaluated  the  vestibular  system  in presence  of   noise  induced  hearing  loss.  Moreover such studies in the  Indian  population  are  lacking.  There  are  no  studies  done  on  the  traffic  policemen  and  automobile  drivers  who  are  vulnerable  to  chronic  noise  exposure  and  where  vestibular  dysfunction  can  have  serious  implications  in  the  day  to  day  discharge  of  duties. Further  early  changes  get  compensated  and  may  not   manifest  as   vestibular  dysfunction.  It  is  not  clear  which  part  of  the  vestibular  function  is  actually  affected  and  whether  the  changes  are  temporary  or  permanent. Our  study  aim to  evaluate  the  vestibular  function  in  cases  of  chronic  noise  exposure  and  also  find  the  levels  of  noise  exposure  at  which  such  changes  occur.  This  can  have  a  far  reaching  effect  in  regularizing  the  safe  sound  levels  at  workplace  and  lead  to  better  occupational  health  by  minimizing  or  avoiding  the  hazards  of  noise  pollution.


 
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