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CTRI Number  CTRI/2025/08/092426 [Registered on: 05/08/2025] Trial Registered Prospectively
Last Modified On: 04/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Impact of increased usage of earphones on the ability to filter out repetitive sounds in young adults  
Scientific Title of Study   Influence Of Recreational Noise On Auditory Sensory Gating Function In Young Adults.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Siri Vasishta H S  
Designation  MSc Audiology Student  
Affiliation  Manipal College for Health Professions, MAHE , Manipal 
Address  Department of Speech and Hearing Manipal College of Health Professions Manipal Academy Of Higher Education Manipal Phone number 08202922577

Udupi
KARNATAKA
576104
India 
Phone  8762457819  
Fax    
Email  siri1.mchpmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Kishan M M 
Designation  Associate Professor  
Affiliation  Manipal College for Health Professions MAHE Manipal 
Address  Department of Speech and Hearing Manipal College of Health Professions MAHE Manipal Phone number 08202922577

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 for Health Professions MAHE Manipal 
Address  Department of Speech and Hearing Manipal College of Health Professions MAHE Manipal Phone number 08202922577

Udupi
KARNATAKA
576104
India 
Phone  9845141575  
Fax    
Email  kishan.m@manipal.edu   
 
Source of Monetary or Material Support  
Department of Speech and Hearing, MCHP,MAHE,Manipal- 576104 
 
Primary Sponsor  
Name  Siri Vasishta H S  
Address  Department of Speech and Hearing Manipal College of Health Professions MAHE Manipal Phone number 08202922577 
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   Kasturba Hospital   Room Number 309 Department of Speech and Hearing Kasturba Hospital Udupi-Hebri Road, Madhav Nagar, Manipal, 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-2 ( Student Research)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Ability to filter out repetitive auditory sounds 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Control Group:
Inclusion Criteria:
Noise Exposure Structured Interview (NESI) unit less than 2
Age range: 18 – 25 years
Hearing sensitivity within normal limits (PTA Hearing thresholds equal or below 25 dB and correlating to speech scores)

Study Group:

Inclusion Criteria:

Noise Exposure Structured Interview (NESI) unit more significant than 2
Exposed to recreational noise – Personal Listening Device users and club attendees Age range: 18 – 25 years
Hearing sensitivity within normal limits (PTA Hearing thresholds equal or below 25 dB correlating to speech scores)
 
 
ExclusionCriteria 
Details  Control Group:
Exclusion Criteria:
Individuals with hearing loss (Greater than 25 dB)
Presence of Tinnitus continuously for more than 6 months
Underlying psychological conditions
Cognitive impairments
Previously diagnosed neuropsychiatric conditions
Any use of drugs and/Alcohol (Avoid exposure for three days prior to data collection)
Under medications that influence sensory gating abilities (Avoid exposure for three days prior to data collection)


Study Group :
Exclusion Criteria:
Individuals with hearing loss (Greater than 25 dB)
Presence of Tinnitus continuously for more than 6 months
Underlying psychological conditions
Cognitive impairments
Previously diagnosed neuropsychiatric conditions
Any use of drugs/Alcohol (Avoid exposure for three days before data collection)
Under medications that influence sensory gating abilities (Avoid exposure for three days prior to data collection)

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Identifying the influence of recreational noise exposure on auditory sensory gating function in young adults   At Baseline  
 
Secondary Outcome  
Outcome  TimePoints 
Relationship between High Frequency Audiometry and SNR50 with auditory sensory gating P50 measures   At baseline  
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
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)   18/08/2025 
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="8"
Days="0" 
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   This study aims to assess the influence of Recreational Noise on Auditory Sensory gating functions in young adults. Participants will be divided into two groups: a control group and a study group. Informed consent and PIS will be provided before proceeding with the tests. Participants will be divided to the respective groups based on the Noise Exposure Structured Interview (NESI) scores and baseline assessments, which include Pure Tone Audiometry, High Frequency Audiometry, SNR50 and Speech Audiometry. The study will use both subjective and objective tests to assess Auditory Sensory Gating function in both groups. Objective tests such as P50 auditory sensory gating recordings using a standardized procedure, and Subjective evaluation, including a questionnaire termed the Sensory Gating Inventory (SGI), will be provided for subjective scoring. This is a cross-sectional, observational study and will be conducted prospectively on young adults aged 18-25 years. Participants will be recruited from the student community at Manipal University, MAHE, Manipal. 

All tests will be held at the Department of Speech and Hearing in Kasturba Hospital, Manipal in a controlled setting. The study findings may help us understand the influence of recreational noise on Auditory Sensory Gating functions in young adults and the study can benefit clients by providing them with insights into their individual addiction levels related to exposure to recreational noise and its impact on their auditory sensory gating. The results will be connected to their social and academic skills.

 
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