| CTRI Number |
CTRI/2020/04/024686 [Registered on: 16/04/2020] Trial Registered Prospectively |
| Last Modified On: |
09/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the remaining hearing capability of children after surgery to insert a hearing device in the ear. |
|
Scientific Title of Study
|
Residual hearing following cochlear implantation: An observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Stuti Chowdhary |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Department of E.N.T.
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7447661928 |
| Fax |
|
| Email |
stuti.9894@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Alexander |
| Designation |
Professor |
| Affiliation |
Department of E.N.T. |
| Address |
Department of E.N.T.
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9443021595 |
| Fax |
|
| Email |
arun.a@jipmer.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Alexander |
| Designation |
Professor |
| Affiliation |
Department of E.N.T. |
| Address |
Department of E.N.T.
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9443021595 |
| Fax |
|
| Email |
arun.a@jipmer.edu.in |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry-605006 |
|
|
Primary Sponsor
|
| Name |
Jipmer Pondicherry |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry- 605006 |
| 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 Stuti Chowdhary |
Ent Opd Jipmer |
Ent Opd
Department of Ent
Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry-605006
Pondicherry
PONDICHERRY |
7447661928
stuti.9894@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITONAL ETHICS COMMITTEE |
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
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
All children who have undergone cochlear implantation at least 6 months before the day of assessment. |
|
| ExclusionCriteria |
| Details |
1. Cochlear implantation done for anatomically abnormal cochlea
2. Children who have undergone a revision cochlear implant in the same ear.
3. Children unable to understand commands for pure tone audiometry.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Residual hearing preservation using the Skarzynski formula. |
June 2020 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the optimum length of electrode array needed to provide electrical stimulation without damage to the residual hearing. |
June 2020 |
|
|
Target Sample Size
|
Total Sample Size="49"
Sample Size from India="49"
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)
|
20/04/2020 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1. Title: Residual hearing following cochlear implantation: An observational study 2. Research hypothesis: a. Cochlear implantation causes damage to the residual hearing b. There is a negative correlation between depth of insertion of a cochlear implant and residual hearing. 3. Primary objective: To evaluate residual hearing after cochlear implantation. 4. Secondary objective: To correlate depth of insertion of electrode array and residual hearing. |