| CTRI Number |
CTRI/2021/01/030685 [Registered on: 22/01/2021] Trial Registered Prospectively |
| Last Modified On: |
21/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of correlation between two hearing assessment test |
|
Scientific Title of Study
|
A STUDY OF COMPARISON OF HEARING THRESHOLD BETWEEN PURE TONE AUDIOMETRY AND AUDITORY STEADY STATE RESPONSE IN ADULT |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashwiniben Parmar |
| Designation |
2nd YEAR ENT RESIDENT of otorhinolaryngology |
| Affiliation |
Sir.T. Hospital and Government medical college,Bhavnagar |
| Address |
Sir T Hospital campus ,GMC Bhavnagar, ENT DEPARTMENT .
Bhavnagar
GUJARAT
364001
India |
| Phone |
8238149460 |
| Fax |
|
| Email |
parmarman126@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushil Jha |
| Designation |
Head of unit of otorhinolaryngology |
| Affiliation |
Sir.T. Hospital and Government medical college,Bhavnagar |
| Address |
Department of ENT, Sir T Hospital, GMC, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9426909700 |
| Fax |
|
| Email |
sushilkgjhatanmay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Andalib daymakumar |
| Designation |
2nd resident Doctor of otorhinolaryngology |
| Affiliation |
Sir.T. Hospital and Government medical college,Bhavnagar |
| Address |
Sir T hospital, GMC,bhavnagar,
Ent department.
Bhavnagar
GUJARAT
364001
India |
| Phone |
8460514913 |
| Fax |
|
| Email |
dayma_andalib@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Department of Otorhinolaryngology,Government medical college, Sir T hospital, Bhavnagar |
|
|
Primary Sponsor
|
| Name |
Department of ENT |
| Address |
Department of Otorhinolaryngology,Government medical college, Sir T hospital, 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 Ashwiniben Parmar |
Sir T Hospital, Bhavnagar |
Department of Otorhinolaryngology,Government medical college, Sir T hospital, Bhavnagar
Bhavnagar
GUJARAT |
8238149460
parmarman126@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 |
| Healthy Human Volunteers |
Person who gives informed and written consent |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients who gave informed and written consent
Subjects having normal hearing
Subjects having hearing loss |
|
| ExclusionCriteria |
| Details |
Subjects who did not give informed and written consent
Patient is not cooperative
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean PTA and ASSR response values in adult
Correlation coefficient for
PTA and ASSR response hearing threshold level in adult
|
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean PTA and ASSR response values in adult
Correlation coefficient for PTA and ASSR response hearing threshold level in adult
|
18 months
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
25/01/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
´Pure tone
audiometry is the gold standard for evaluation of hearing level. Audiometers
are used to make quantitative measurements of pure tone air and bone conduction
thresholds. In certain case like small children, patient with
developmental/neurological delay, patients requiring medico legal auditory
evaluation are example of difficult to test population .
´Infant hearing
loss should be identified and treated early to prevent delay in the development
of speech and language at 6 months of age is a critical issue that relates to
future performance in speech and language
With the
advent of universal new born hearing screening, all the children need a
comprehensive audiological evaluation. There is a need of accurate estimation
of hearing threshold ,both for
appropriate hearing aid fitting and correct indication of cochlear
implantation´This is a
multiple auditory steady evoked response ( MASTER) acquisition system .
Auditory steady state response (ASSR) is an objective PTA , which can assess
both air conduction( AC ) and bone conduction( BC ). It generate multiple
frequency modulated stimulus and acquires electrophysiological response to
these stimulus.
|