| CTRI Number |
CTRI/2023/07/054709 [Registered on: 04/07/2023] Trial Registered Prospectively |
| Last Modified On: |
03/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Ambispective |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of short term and long term effects of cochlear implantation on vestibular function |
|
Scientific Title of Study
|
Evaluation of short term and long term effects of cochlear implantation on vestibular function |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrPrem Sagar |
| Designation |
Additional professor,DEPT OF ENT & HNS |
| Affiliation |
Aiims Delhi |
| Address |
Hostel 19,aiims Delhi hostel campus
Masjid moth
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9868078734 |
| Fax |
|
| Email |
sagardrprem@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPrem Sagar |
| Designation |
Additional professor,DEPT OF ENT & HNS |
| Affiliation |
Aiims Delhi |
| Address |
Hostel 19,aiims Delhi hostel campus
Masjid moth
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9868078734 |
| Fax |
|
| Email |
sagardrprem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrPrem Sagar |
| Designation |
Additional professor,DEPT OF ENT & HNS |
| Affiliation |
Aiims Delhi |
| Address |
Hostel 19,aiims Delhi hostel campus
Masjid moth
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9868078734 |
| Fax |
|
| Email |
sagardrprem@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of ENT AND HNS,AIIMS DELHI |
| Address |
Aiims delhi |
| 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 |
| DrMehak Arora |
Department of ENT AND HNS |
Aiims delhi
New Delhi
DELHI |
7652852049
aroramehak19041995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H818||Other disorders of vestibular function, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
-Cochlear implantees more than or equal to 12 years old
-Implantation surgery performed atleast 12 months ago
-Implant users or non-users
-Willing to participate
-Ability to understand and answer the relevant questions |
|
| ExclusionCriteria |
| Details |
Patients with history of any of the following symptoms prior to cochlear implantion
Otorrhoea
Previous ear surgery
Dizziness
Imbalance
Vertigo
Head trauma
Significant differences in anatomical abnormalities between the operated and non operated ear
Patients unwilling to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of long-term effect of cochlear implantation on vestibular function
|
2years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Evaluation of the correlation between the effect of congenital Vs acquired etiology of SNHL and the vestibular function in the cochlear implantees.
2. Evaluation of association between patients’ perception of balance and the laboratory measurement of vestibular function
3.Assessment of the effect of vestibular function with the speech and language outcome of cochlear implant |
2 years |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
12/07/2023 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 11-05-2023 and end date provided 11-05-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Cochlear implantation may have a detrimental effect on vestibular function and residual hearing which have been made evident in several studies but the long term effects of such things is not assessed in detail yet.
Since we have a robust data on more than 20 patients and would be expecting around 15 more to add to the study , we are expecting a reasonably good sample size.
The study also aims at investigating various factors which were not well elucidated and results obtained in this study would be substantial and are likely to build up on the existing knowledge on Importance of the integrity of vestibular system in the overall outcome of cochlear implant recepients
|