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CTRI Number  CTRI/2024/04/065221 [Registered on: 04/04/2024] Trial Registered Prospectively
Last Modified On: 04/04/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Hospital record based study 
Study Design  Other 
Public Title of Study   Demographic profile of deafness (2018-2021) 
Scientific Title of Study   Demographic Profile of Hearing Deficiency in an Urban Referral Hospital (2019-2022) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Indranil Sen 
Designation  Professor 
Affiliation  College of medicine and Sagore Dutta Hospital  
Address  Department of Otorhinolaryngology College of Medicine and Sagore Dutta Hospital 578 B.T. Road. Kamarhati

North Twentyfour Parganas
WEST BENGAL
700058
India 
Phone  9749283857  
Fax    
Email  indranilsen.india@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Indranil Sen 
Designation  Professor 
Affiliation  College of medicine and Sagore Dutta Hospital  
Address  Department of Otorhinolaryngology College of Medicine and Sagore Dutta Hospital 578 B.T. Road. Kamarhati


WEST BENGAL
700058
India 
Phone  9749283857  
Fax    
Email  indranilsen.india@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Indranil Sen 
Designation  Professor 
Affiliation  College of medicine and Sagore Dutta Hospital  
Address  Department of Otorhinolaryngology College of Medicine and Sagore Dutta Hospital 578 B.T. Road. Kamarhati


WEST BENGAL
700058
India 
Phone  9749283857  
Fax    
Email  indranilsen.india@gmail.com  
 
Source of Monetary or Material Support  
College of Medicine and sagore Dutta Hospital 578 Barrackpore Trunk Road Kamarhati Kolkata 700035 
 
Primary Sponsor  
Name  College of Medicine and Sagore Dutta Hospital 
Address  578 B.T.Road Kamarhati Kolkata- 700058 
Type of Sponsor  Government medical college 
 
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 Anup Kumar Das   College of Medicine and Sagore Dutta Hospital  Department of Otorhinolaryngology College of Medicine and sagore Dutta Hospital 578 Barrackpore Trunk Road Kamarhati Kolkata 700058
North Twentyfour Parganas
WEST BENGAL 
6290853295

anoopdas70@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC College of Medicine And Sagore Dutta Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H908||Mixed conductive and sensorineuralhearing loss, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Persons reporting with deafness  
 
ExclusionCriteria 
Details  Persons without deafness 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Estiamtion of case load and Demographic profile of population with deafness   30 days  
 
Secondary Outcome  
Outcome  TimePoints 
Estiamtion of case load & Demographic profile of population with deafness   30 days  
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
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)   22/04/2024 
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="3"
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  

The ear is a unique organ that gives us the modality of hearing. The ear can be damaged by variety of factors such as different disease processes, trauma, excessive exposure to noise, effect of some drugs and aging process. All these factors lead to malfunction of ear resulting in some kind of hearing loss.

The health and quality of life is affected tremendously by hearing loss. The common ear diseases such as wax, infections of external auditory canal and infections of middle ear cleft such as Acute Otitis Media, Chronic Otitis Media, Otitis Media with Effusion carries a significant proportion of causes that lead to deafness. All these conditions can be diagnosed early and managed properly to reduce the overall burden of deafness throughout the globe.

The sense of hearing carries a very important role in the process of communication. Deafness is a cause of major morbidity the goes very often undiagnosed and unreported even in a tertiary health care facility. This causes a major problem in the planning of future management of hearing loss because of non-availability of proper database in our health system. The purpose of our study is to analyze the demographic characteristics of individuals presenting with hearing loss in an urban referral hospital using the available database of pure tone audiometry results.

 
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