| CTRI Number |
CTRI/2024/11/077390 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
19/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Correlation of Auditory and Speech Outcome with Electrode Modiolus distance after Cochlear Implantaton in Children with Prelingual deafness
|
|
Scientific Title of Study
|
Correlation of Auditory and Speech Outcome with Electrode Modiolus distance after Cochlear Implantaton in Children with Prelingual deafness |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sindhamani M |
| Designation |
Academic Junior resident |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Otorhinolaryngology, All India Institute of Medical Sciences, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7010043125 |
| Fax |
|
| Email |
sindhamanim1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Goyal |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Otorhinolaryngology, All India Institute of Medical Sciences, Jodhpur, Basni, Jodhpur 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996881 |
| Fax |
|
| Email |
meetugoyal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sindhamani M |
| Designation |
Academic Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Otorhinolaryngology, All India Institute of Medical Sciences, Jodhpur, Basni, Jodhpur 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7010043125 |
| Fax |
|
| Email |
sindhamanim1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Jodhpur, Basni, Jodhpur - 324005 |
|
|
Primary Sponsor
|
| Name |
Research Section All India Institute of Medical Sciences Jodhpur |
| Address |
All India Institute of Medical Sciences, Jodhpur, Basni, Jodhpur 342005 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sindhamani M |
All India Institute of Medical Sciences, Jodhpur |
Department of Otorhinolaryngology,
All India Institute of Medical Sciences, Jodhpur
Jodhpur
RAJASTHAN |
7010043125
sindhamanim1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All India Institute of Medical Sciences Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H839||Unspecified disease of inner ear, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cochlear Implantation |
Procedure of inserting electrodes in Cochlea in children with Profound deafness |
| Comparator Agent |
Electrode Modiolus Distance |
Electrode Modiolar Distance calculated using HRCT temporal bones and compared with Audiological outcomes |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Pre lingual deaf children undergoing cochlear implantation surgery in All India Institute of Medical Sciences, Jodhpur |
|
| ExclusionCriteria |
| Details |
1. Inner ear anomalies
2. History of middle or inner ear surgery
3. Contraindication or difficulty for undergoing postoperative radiology
4. Parents or guardian not willing for the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Auditory and verbal outcomes as measured by aided audiogram, ASSR and CAP & SIR scores respectively after 12 months |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| explore potential factors influencing electrode-modiolar distance including cochlear parameters, round window variation and method of insertion |
1 year |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
02/12/2024 |
| 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
|
Pre lingual deaf children undergoing cochlear implantation surgery.Complete clinical, audiological & radiological evaluation; *Cochlear morphology & parameters will done for individual child.Cochlear implantation will done.Radiologic assessment of EMD of 1st, 6th & 12th electrode done post operatively.Assessment of audiological outcomes by aided audiogram & ASSR, Speech outcomes by CAP & SIR scores at 12 months; Correlation between EMD and outcomes will done.
|