| CTRI Number |
CTRI/2025/02/081114 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device Screening |
| Study Design |
Other |
|
Public Title of Study
|
Testing of low cost Hearing screening device |
|
Scientific Title of Study
|
HearIT - A low cost hearing screening device |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kapil Sikka |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
4060, Department of ENT, Teaching Block, AIIMS, Ansari Nagar, New Delhi
South DELHI 110029 India |
| Phone |
9810423088 |
| Fax |
01126594922 |
| Email |
kapil_sikka@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Kapil Sikka |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
4060, Department of ENT, Teaching Block, AIIMS, Ansari Nagar, New Delhi
South DELHI 110029 India |
| Phone |
9810423088 |
| Fax |
01126594922 |
| Email |
kapil_sikka@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Kapil Sikka |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
4060, Department of ENT, Teaching Block, AIIMS, Ansari Nagar, New Delhi
South DELHI 110029 India |
| Phone |
9810423088 |
| Fax |
01126594922 |
| Email |
kapil_sikka@yahoo.com |
|
|
Source of Monetary or Material Support
|
| The Indian Council of Medical Research (ICMR)
Ansari Nagar, New Delhi
India
Pin Code-110029 |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
The Indian Council of Medical Research (ICMR), Ansari Nagar New Delhi, India
Pin Code-110029 |
| Type of Sponsor |
Government funding agency |
|
|
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 Kapil Sikka |
All India Institute of Medical Science |
Room No. 613, 6th Floor, New Raj Kumari Out patient department, Department of Otorhinolaryngology and Head and Neck Surgery, All India Institute of Medical Science, Ansari Nagar, New Delhi South DELHI |
9810423088
kapil_sikka@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Commitee, All India Institute of Medical Sciences, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal Hearing |
| Patients |
(1) ICD-10 Condition: H908||Mixed conductive and sensorineuralhearing loss, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hear IT,
Hearing screening device |
The device will be used to perform hearing screening test non-invasively in the mentioned population during the course of the study. HearIT is a DPOAE (Distortion-Product Otoacoustic Emissions) based hearing screening device. It is a hearing screening tool that uses sound to evaluate the health and function of the inner ear. Any individual with minimal training shall be able to operate the device.
After initial calibration, the probe is inserted in subject’s ear canal firmly and the test will be run automatically by the system. The assessment will be a one time assessment wherein the evaluation will be performed once in each individual and the values obtained will be compared with the values of standard device. |
| Comparator Agent |
Neuro Audio, Hearing screening device |
It is a standard device currently being used for screening the individuals for hearing deficits in hospitals and medical set ups. It includes standard tests such as Otoacoustic emissions (OAE) and Automated auditory brainstem responses (AABR). The test that will be performed for the present study is Distortion product Otoacoustic emissions (DPOEA). The DPOAEs will be performed on all the subjects once using this device and the Hear IT device each and the values obtained will be compared. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Individual with and without Hearing loss within the specified age range |
|
| ExclusionCriteria |
| Details |
Patients Not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study is to determine the signal to noise ration and percentage of individuals passing or failing the screening test with experimental and standard devices. Subsequently, it will be employed to calculate sensitivity, specificity, positive predictive value, and negative predictive value. |
The outcomes of both the devices will be evaluated at the end of data collection. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Secondary outcome of the study will be comparative values of sensitivity, specificity, positive predictive & negative predictive values using both the devices in different age groups. |
All the analysis will be perform at the end of data collection. |
|
|
Target Sample Size
|
Total Sample Size="614" Sample Size from India="614"
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)
|
01/03/2025 |
| 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="5" Months="0" 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
|
Hearing
impairment is one of the serious disabilities but is often neglected in India.
The individual with hearing loss in the country often suffer due to lower wages
and inadequacy of facilities for them. This causes more financial burden and
higher unemployment rate. The neonatal hearing screening (NHS) programme is
universally recommended and accepted means for early identification and
intervention of congenital hearing loss. Initially targeted for babies at high
risk, Universal Neonatal Hearing Screening (UNHS) now stands for arrangement of,
screening every neonate born in the hospital. The implementation of UNHS has
been shown to reduce the age of identification of hearing impairment
significantly and minimize the overall effect of hearing loss on an
individual’s life. In India, the programme implementation is still in initial
phase and monitoring children as well as adults regularly is almost
non-prevalent. This can be majorly attributed to currently available expensive
hearing screening devices. Further, such equipment may only be used by
specialists such as audiologists, who are in shortage. In this project we will
completely re-engineer such a screening device in order to significantly bring
down its cost, enable it to be used by laypersons in the same manner that we
use blood pressure monitors or thermometers and make suitable for use in
different surroundings without requiring a no-ambient noise setting. More
widespread availability of low-cost screening devices will enable their usage
in schools, small healthcare centres, factories and construction sites. This in
turn will help with the detection of hearing impairment and the affected individuals
may be referred for treatment early on, thereby significantly improving the
chances of recovery and prevent further deterioration. |