| CTRI Number |
CTRI/2024/03/064818 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
25/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
EVALUATION OF BRAIN ACTIVITY CHANGES AFTER COCHLEAR IMPLANTATION AS SEEN ON FNIRS |
|
Scientific Title of Study
|
TO EVALUATE PROSPECTIVE AUDITORY CORTICAL ACTIVITY CHANGES ON FUNCTIONAL NEAR INFRARED SPECTROSCOPY IN PRELINGUAL PROFOUND SNHL PATIENTS UNDERGOING COCHLEAR IMPLANTATION |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mridul Sharma |
| Designation |
Junior Resident (Acad.) |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No. 4057, Dept. of ENT, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
South West
DELHI
110029
India |
| Phone |
7339747750 |
| Fax |
|
| Email |
mridulsharma05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arvind Kumar Kairo |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No. 4057, Dept. of ENT, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
South West
DELHI
110029
India |
| Phone |
9868491991 |
| Fax |
|
| Email |
arvindkairo@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Arvind Kumar Kairo |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No. 4057, Dept. of ENT, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
South West
DELHI
110029
India |
| Phone |
9868491991 |
| Fax |
|
| Email |
arvindkairo@yahoo.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
Mridul Sharma |
| Address |
Room No. 4057, Dept of Otorhinolaryngology, AIIMS, New Delhi, 110029 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| MRIDUL SHARMA |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
DEPT OF OTORHINOLARYNGOLOGY, ROOM NO. 4057, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI, 110029
South West
DELHI |
7339747750
MRIDULSHARMA05@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H903||Sensorineural hearing loss, bilateral, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL
|
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Pre-lingual bilateral profound sensory-neural hearing loss patients who are planned for cochlear implantation
2. Those who give consent
3. Those who have funds deposited in AIIMS for CI
|
|
| ExclusionCriteria |
| Details |
1. Those who do not fit in inclusion criteria
2. Those who do not give consent
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of the prospective auditory cortical activity changes on fNIRS in prelingual profound SNHL patients undergoing cochlear implantation. |
1. pre cochlear implant
2. 1 month post CI
3. 6 month post CI |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of cortical activity changes on fNIRS with audioverbal outcome scores (CAP, SIR, MAIS) |
1. pre cochlear implant
2. 1 month post CI
3. 6 month post CI |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
10/04/2025 |
| 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="2"
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
|
This study has been designed for the evaluation of the benefit of cochlear implantation by observing the changes of auditory cortical activity on fNIRS. Also the auditory cortical activation data can be used to compare the diverse factors hindering the outcomes after cochlear implantation. To prognosticate the cases post cochlear implantation and implement timely intervention if cortical activation is not upto the mark. A standardized test for prognosticating, evaluating and monitoring the cochlear implantee can be set up, if the study turns fruitful. |