| CTRI Number |
CTRI/2022/07/043853 [Registered on: 08/07/2022] Trial Registered Prospectively |
| Last Modified On: |
07/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
comparision of OAE and BERA hearing test as a screening of hearing loss in children (12 year) |
|
Scientific Title of Study
|
A comparative study of OAE(otoacoustic emission) and BERA(Brainstem evoked response
audiometry)as a screening of hearing loss among the patients for hearing
assesment in ENT OPD(less than 12 years) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Monika Chaudhari |
| Designation |
1st year ENT resident |
| Affiliation |
Government medical college bhavnagar |
| Address |
ENT department, Sir T hospital campus,jail road,Bhavnagar
ENT department,sir T hospital campus,jail road,Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9099898666 |
| Fax |
|
| Email |
makuchaudhari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushil G Jha |
| Designation |
Professor and Head of the department of ENT |
| Affiliation |
Government medical college |
| Address |
Sir T General Hospital,jail road,Bhavnagar
Bhavnagar
ENT Department,sir T hospital campus,Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9426909700 |
| Fax |
|
| Email |
sushilkgjhatanmay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushil G Jha |
| Designation |
Professor and Head of the department of ENT |
| Affiliation |
Government medical college |
| Address |
Sir T General Hospital,jail road,Bhavnagar
Bhavnagar
ENT Department,sir T hospital campus,Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9426909700 |
| Fax |
|
| Email |
sushilkgjhatanmay@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of otorhinolaryngology,Sir T Hospital,Government medical college,Bhavnagar |
|
|
Primary Sponsor
|
| Name |
Department of Otorhinolaryngology |
| Address |
Sir T general Hospital,Jail road,Bhavnagar |
| 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 Monika chaudhari |
Sir T General hospital bhavnagar |
Roon no 104 P G 2 hostel,Sir T General
Hospital
,Bhavnagar
Bhavnagar
GUJARAT
Bhavnagar
GUJARAT |
9099898666
makuchaudhari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB,GMC,Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Children age group <12 years of age
2.Patient comes in ENT
OPD including ear complain
3.Children reffered by pediatrician
on susoicious of hearing loss/speech delay/presence of any high risk
factor
4.Chlidren brought by parents suspicious of hearing loss or speech delay |
|
| ExclusionCriteria |
| Details |
1.Patient with absent external auditory canal,meatal
atresia,anomalies of the external where probe insertion not possible
2.Tympanic membrane perforation
3.Children with purulent ear discharge,acute suppurative otitis media
conditions of ear like external impacted wax were included in study after the condition was treated |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Which test give better result between OAE and
BERA as a screening modality of hearing loss |
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| which test is prefer for early intervention of hearing loss |
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
11/07/2022 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
My study is about a comparision of OAE(otoacoustic emission) and BERA(Brainsten evoked response audiometry) ass a screening of hearing loss in children. children between 0-12 year children will be considered for study. In all 100 patients both OAE and BERA will be performed and at the end compare both this as which is better modality for screening.
|