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CTRI Number  CTRI/2023/08/056957 [Registered on: 25/08/2023] Trial Registered Prospectively
Last Modified On: 24/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Effects of recreational noise on auditory listening skills 
Scientific Title of Study   Influence of Recreational Noise Exposure on Cochlear Synaptic Functions in College-Going Students 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Michal Jacob 
Designation  Postgraduate Student 
Affiliation  Manipal College of Health Professions 
Address  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi Karnataka- 576104 India

Udupi
KARNATAKA
576104
India 
Phone  9632209917  
Fax    
Email  michal.mchpmpl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Kishan M M 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi Karnataka- 576104 India

Udupi
KARNATAKA
576104
India 
Phone  9845141575  
Fax    
Email  kishan.m@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Kishan M M 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi Karnataka- 576104 India


KARNATAKA
576104
India 
Phone  9845141575  
Fax    
Email  kishan.m@manipal.edu  
 
Source of Monetary or Material Support  
Department of Speech and Hearing, Kasturba Medical Hospital, Manipal 
 
Primary Sponsor  
Name  Michal Jacob 
Address  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka-576104 
Type of Sponsor  Other [Self] 
 
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 
Dr Kishan M M  Manipal College of Health Professions  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka- 576104
Udupi
KARNATAKA 		 9845141575

kishan.m@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  College students 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  College going students between 18-30 years of age. 
 
ExclusionCriteria 
Details  Individuals with middle ear problems.
Pre-existing hearing loss.
Neurological or medical conditions that influence auditory and cognitive functions. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
NESI- total units of noise exposure,
Electrophysiological measure -Amplitude (microvolt) / latency of wave I (millisecond),
FFR peaks latency (millisecond),
SP/AP ratio 		 11 months 19 days 
 
Secondary Outcome  
Outcome  TimePoints 
Association between recreational noise exposure & FFR  11 months 19 days 
 
Target Sample Size   Total Sample Size="132"
Sample Size from India="132" 
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)   01/09/2023 
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="0"
Months="11"
Days="20" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Aim: To study the influence of recreational noise exposure on cochlear synaptic functions in college-going students.

Objectives: 
  1. To estimate the recreational noise exposure levels
  2. To assess the influence of recreational noise on ABR wave I latency, amplitude and FFR
  3. To study the association between recreational noise exposure and ABR and FFR
Justification for study: Listening difficulty and poor speech perception is common in cochlear synaptopathy, which is also reported by chronic recreational noise exposure individuals. However, till date the relationship is not established. Hence there is a need to see the influence and association of recreational noise and synaptic function.

Procedure: This study involves the administration of the Noise Exposue Structured Interview (Guest et al, 2018) to estimate a person’s lifetime noise exposure. After this individuals are grouped into 3 groups. Group 1- No noise/ occasional users of PLDs or recreational noise exposure, 2- Predominant PLD users, 3- Combined PLD and recreational noise exposure. Then Pure Tone Audiometry along with Extended High Frequency Audiometry and Speech-in-noise test are done. Otoacoustic emissions, Electrocochleography, ABR and Frequency Following Response will also be done.





 
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