| CTRI Number |
CTRI/2024/01/062098 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
29/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the relationship between adult hearing loss and hearing -related discomfort |
|
Scientific Title of Study
|
Influence of hearing Loss on listening related fatigue among adults with hearing loss |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K L Ramya |
| Designation |
Student |
| Affiliation |
Manipal College Of Higher Education |
| Address |
Department of speech and hearing Manipal college of health professions Manipal college of higher Education
Udupi
Karnataka
India
Udupi
KARNATAKA
576104
India |
| Phone |
6362558079 |
| Fax |
|
| Email |
ramya.mchpmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
DrHari Prakash |
| Designation |
Associate Professor |
| Affiliation |
Manipal College Of Higher Education |
| Address |
Department of speech and hearing Manipal college of health professions Manipal college of higher Education
Udupi
Karnataka
India
Udupi
KARNATAKA
576104
India |
| Phone |
9886135522 |
| Fax |
|
| Email |
hari.prakash@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DrShubhaganga |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College Of Higher Education |
| Address |
Department of speech and hearing Manipal college of health professions Manipal college of higher Education
Udupi
Karnataka
India
Udupi
KARNATAKA
576104
India |
| Phone |
8310851665 |
| Fax |
|
| Email |
shubhaganga.d@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Self Financed ( Department of speech and hearing Manipal College of Health Professions Manipal Karnataka) |
|
|
Primary Sponsor
|
| Name |
K L Ramya |
| Address |
Department of speech and hearing MCHP MAHE |
| Type of Sponsor |
Other [Self ] |
|
|
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 Hari Prakash |
Kasturba Hospital,Manipal |
Room number 27,Department of speech and hearing ,Manipal
Udupi
KARNATAKA |
9886135522
hari.prakash@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturabha medical college and kasturabha Hospital institutional ethics commitee-2 ( student research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal hearing sensitivity |
| Patients |
(1) ICD-10 Condition: H838||Other specified diseases of innerear, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
24.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Group 1: Individuals with mild to severe sensorineural hearing loss ( Age range from 18 to 45 years)
Group 2: Individuals with normal hearing sensitivity under same age group |
|
| ExclusionCriteria |
| Details |
Group 1 : No known symptoms of cognitive or neurological problems.
No cases of middle ear and conductive pathologies
Group 2 : Individuals with no degree of hearing loss and no known symptoms of cognitive or neurological causes |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vander Bilt Fatigue Scores |
Two time points |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="306"
Sample Size from India="306"
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)
|
12/02/2024 |
| 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="0"
Months="10"
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
|
This observational study consists of 2 groups .Group 1 : Individuals with mild to severe sensorineural hearing loss and Group 2 : Consists of normal hearing sensitivity. participants will be recruited from Audiology OPD who meets the above mentioned criteria and Vanderbilt Fatigue scale questionnaire will be given to them ( which assesses listening related fatigue ) and VFS will also be given to normal individuals . Then scores of the VFS will be compared between normal hearing and individuals with hearing loss . As a part of PHASE 2 study ,if individuals with hearing loss are ready to recruit the hearing aid then after fitting the hearing aid 3 months later the acclimatization period once again VFS scale will be given and listening related fatigue is analyzed to check whether any decrement is seen after amplification or not ( This will be done as a pilot study if possible). |