FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/073591 [Registered on: 09/09/2024] Trial Registered Prospectively
Last Modified On: 02/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Measuring loudness intolerance in general factory workers 
Scientific Title of Study   Evaluation of loudness intolerance amoung general factory workers  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Liyona Alex 
Designation  Post Graduate 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

Udupi
KARNATAKA
576104
India 
Phone  9074819683  
Fax    
Email  liyona.mchmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Archana G 
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

Udupi
KARNATAKA
576104
India 
Phone  9986516039  
Fax    
Email  archana.maiya@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Archana G 
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 
Phone  9986516039  
Fax    
Email  archana.maiya@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Health Professions(MCHP), Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi, Karnataka, India 576104. 
 
Primary Sponsor  
Name  Liyona Alex 
Address  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India, 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 Archana G  Kasturba Hospital  Department of Speech and Hearing, 3rd floor, Above A2 ward, CTC Building, Baliga block, Kasturba hospital, Madhav Nagar, Manipal, Karnataka, India ,576104
Udupi
KARNATAKA 		 9986516039

archana.maiya@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KMC and KH Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy participants of 20 to 50 years 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Adult age range (20 – 50) years
2. Adult who are exposed to occupational noise more than one year
3.Both male and Female
4. Pure Tone Average of (15 dbHL-40dBHL) Normal to mild hearing loss range.  
 
ExclusionCriteria 
Details  1.Individuals with significant medical illness,
Such as non k/c/o Hypertension, non k/c/o Diabetes and conductive hearing loss. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Hearing sensitivity is obtained as dBHL.
Both the questionnaires are measured as scores.  		 All of the tests listed above will be assessed at one specific time point. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL
 
 
Target Sample Size   Total Sample Size="41"
Sample Size from India="41" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  
Title: Evaluation of Loudness Intolerance Among General Factory Workers

Type of Study: Prospective cross-sectional study

Aims & Objectives:
1. Quantify noise exposure among factory workers exposed to occupational noise.
2. Assess loudness intolerance in individuals with occupational noise exposure.
3. Correlate noise exposure with loudness discomfort levels.
4. Justify study: This study is significant as loudness intolerance due to noise exposure is under-researched, despite its potential impact on workers’ auditory health.

Departments Involved: Department of Speech and Hearing

 Study Period:
- IRC and IEC Approvals: 3 months
- Data Collection: June 2024 - February 2025
- Analysis & Thesis Submission: March 2025

Sample Size:
- Estimated Sample Size: 41
- Calculation: Based on correlation coefficient (r = 0.425), 80% power, and 5% significance level.

 Materials and Methods:
- Inclusion Criteria:
  - Adults (20-50 years)
  - Exposed to occupational noise for over a year
  - Normal to mild hearing loss (Pure Tone Average: 15-40 dB HL)
- Exclusion Criteria:
  - Significant medical illnesses (e.g., hypertension, diabetes)
  - Conductive hearing loss

 Biological Materials Required: None

Statistical Methods:
  - Software: Jamovi version 2.3.28
  - Tests: Shapiro-Wilk test for normality, descriptive statistics, Pearson/Spearman correlation.

Tools Used:
  - Noise Exposure Questionnaire (NEQ): Assesses annual noise exposure; reliable, permission obtained.
  - Modified Khalfa Hyperacusis Questionnaire (HQ): Assesses loudness intolerance; validated, permission obtained.

Procedure:
1. Obtain ethical and CTRI approvals.
2. Measure factory noise levels with a Sound Level Meter (SLM).
3. Screen workers with a portable audiometer.
4. Administer NEQ and HQ questionnaires.
5. NEQ determines annual noise exposure (LAeq8760h). HQ assesses loudness intolerance, with scores indicating severity.

Outcome Measures:
- Hearing Sensitivity: Measured in dB HL.
- Questionnaire Scores: NEQ for noise exposure, HQ for loudness intolerance.

 Potential Risks and Benefits:
- Risks: Possible mental exhaustion and disruption of work.
- Benefits: Contributes to understanding the impact of noise exposure and loudness intolerance, potentially guiding future auditory health measures.

 Ethical Considerations:
- Obtain IEC and IRC clearances and CTRI approval.
- Informed consent from participants.
- Confidentiality of data.
- Participants will receive some form of reinforcement.

 Budget:
- Not applicable

 Review of Literature:
- Workers in noisy environments are at increased risk of loudness intolerance, alongside other auditory issues such as tinnitus and hearing loss. Prior research mainly focuses on hearing loss, with limited studies on loudness intolerance. This study aims to fill the gap by exploring how noise exposure affects loudness intolerance, essential for effective auditory rehabilitation and worker protection in noisy environments.
 
Close