| 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
|
|
|
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
|
|
|
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. |