| CTRI Number |
CTRI/2025/03/082786 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
"Does turning on a cochlear implant machine during surgery will help kids hear better ? A Study on Hearing and Implant performance on change of approach |
|
Scientific Title of Study
|
Randomized Control Trial to Analyse the Effect of Intra
Operative Switch On (IOSO) of Cochlear Implant as Compared To Delayed Switch On of
Cochlear Implant On Electrical Impedance Measurement and Auditory Skills Development
In Pediatric Patients With Congenital Profound Idiopathic Non-Syndromic SNHL |
| 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 Swapnil Agarwal |
| Designation |
Junior Resident |
| Affiliation |
AIIMS , New Delhi |
| Address |
Department OF Otorhinolaryngology , AIIMS New Delhi , Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9079667572 |
| Fax |
|
| Email |
agarwalswapnil2013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prem Sagar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Otorhinolaryngology , AIIMS New Delhi ,Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
8130069892 |
| Fax |
|
| Email |
sagardrprem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prem Sagar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Otorhinolaryngology , Aiims New Delhi ,Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
8130069892 |
| Fax |
|
| Email |
sagardrprem@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS NEW DELHI , Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS , NEW DELHI |
| Address |
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
| 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 Swapnil Agarwal |
AIIMS , New Delhi |
Dept of Otorhinolaryngology and HNS , Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI |
9079667572
agarwalswapnil2013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, All India Institute of Medical Sciences, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intra Operative Switch On of the Cochlear Implant |
Cochlear Implant device will be switched on during the surgery only , that would take additional 10-15 minutes during the surgery |
| Comparator Agent |
Post Operative Switch On of Cochlear Implant |
Cochlear Implant Device Will be Switched ON Post Operatively After 2-3 Weeks In Control Group . It will require one extra visit by patient on OPD basis and will take around 30-45 min |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Pediatric patient between Age 9 Months to 5 years with suitable Candidacy
AND Patient with Congenital Idiopathic Profound SNHL planned for Cochlear Implant with caregivers willing for Follow up Of 6 Months |
|
| ExclusionCriteria |
| Details |
Patient with significant cognitive impairment which may affect speech and language
development AND Intraoperative complications during surgery that may preclude IOSO |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Compare Electrical Impedance of
Cochlear Implant electrodes between
patients who undergo IOSO and those with
delayed Switch ON (between 2wks-4wks)
|
6 MONTHS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the Auditory outcome
between two groups using
standardized tests to evaluate if
IOSO leads to earlier Auditory
stimulation leading faster acquisition
of auditory skills and speech
perception. |
6 MONTHS |
Impact of early switch ON the
battery usage of the implant as
compared to delayed switch ON |
6 MONTHS |
To observe complications related to
wound healing for both the groups
|
6 MONTHS |
To assess the cost incurred by the
hospital and family of the children
and analyze the reduction in
financial burden on them as a result
of same day switch on. |
6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
29/03/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 study aims to improve the existing approach of Cochlear Implant technique. The patient will be enrolled in two groups will, one in which Cochlear Implant machine will be Switched On 2-4 weeks after the surgery , and the child will start hearing after 2- 4 weeks which is the conventional approach being used . Second Group will include children who will receive new approach of Cochlear Implant technique of switching it on during the surgery only i.e. the child will start hearing immediately after the surgery. Two groups will be compared and will be followed for a period of 6 months after the surgery, where child will be assessed for how early he/she is able to listen and respond to the surroundings and how better his learning is . Also, the effect of this new approach on expenses incurred by parents as well as hospital will be studied . The effect of this approach on the battery life and durability of the device will be also be studied and compared between the two groups. |