| CTRI Number |
CTRI/2018/08/015230 [Registered on: 08/08/2018] Trial Registered Prospectively |
| Last Modified On: |
06/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Adaptation and Validation of "Hearing Satisfaction Scale" in Kannada |
|
Scientific Title of Study
|
Cross-cultural Adaptation and Validation of Hearing Satisfaction Scale in Kannada |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
As ham sheleel VS |
| Designation |
student |
| Affiliation |
Manipal academy of higher education |
| Address |
2nd MASLP
dept. of speech and hearing
SOAHS
Manipal academy of higher education
udupi
karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
7204235099 |
| Fax |
|
| Email |
sheleelasham@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Kanaka |
| Designation |
Associate Professor |
| Affiliation |
Manipal academy of higher education |
| Address |
Department of Speech and Hearing
SOAHS
Manipal academy of higher education
udupi
karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9845384136 |
| Fax |
|
| Email |
g.kanaka@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Kanaka |
| Designation |
Associate Professor |
| Affiliation |
Manipal academy of higher education |
| Address |
Department of Speech and Hearing
SOAHS
Manipal academy of higher education
udupi
karnataka
KARNATAKA
576104
India |
| Phone |
9845384136 |
| Fax |
|
| Email |
g.kanaka@manipal.edu |
|
|
Source of Monetary or Material Support
|
| kasturba medical college
manipal
karnataka |
|
|
Primary Sponsor
|
| Name |
Department of Speech and Hearing |
| Address |
SOAHS
Manipal Academy of Higher Education
manipal
karnataka |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Gkanaka |
department of speech and hearing
SOAHS
Manipal academy of higher education
manipal
karnataka |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| As Ham Sheleel VS |
School of Allied Health Sciences |
Department of Speech and Hearing
Kasturba Hospital
Manipal
Udupi
Karnataka
Udupi
KARNATAKA |
7204235099
sheleelasham@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC & KH INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H902||Conductive hearing loss, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Degree of loss: Upto Moderately severe hearing loss (Ac thresholds < 65dBHL)
Type of loss: Conductive / Mixed loss (BC threshold / Conductive component of ≤ 20dB at 0.5, 1, 2 kHz)
Unilateral or bilateral loss
Minimum education level: 10th standard
|
|
| ExclusionCriteria |
| Details |
Previous history of ear surgery
No exposure to occupational noises
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HEARING SATISFACTION SCORES ON 10 QUESTIONS |
one time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
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 1 |
|
Date of First Enrollment (India)
|
10/08/2018 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
the adapted 10 item self report questionnaire will be administered on the participants and the results will be used to understand how presence of Conductive hearing loss impacts the quality
of life of an individual. |