| CTRI Number |
CTRI/2024/04/065271 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
27/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Audiological rehabilitation] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Development of training program for adults with hearing loss |
|
Scientific Title of Study
|
Development and validation of aural rehabilitation module for adults with hearing loss and their significant others |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Spoorthi G N |
| Designation |
Research Scholar |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Audiology and Speech Language Pathology, Kasturba Medical College, Bejai campus, Mangalore-575004
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9483056500 |
| Fax |
|
| Email |
spoorthi.mchpmlr2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Usha Shastri |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Audiology and Speech Language Pathology, Kasturba Medical College, Bejai campus, Mangalore-575004
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9449821455 |
| Fax |
|
| Email |
usha.shastri@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Spoorthi G N |
| Designation |
Research Scholar |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Audiology and Speech Language Pathology, Kasturba Medical College, Bejai campus, Mangalore-575004
Dakshina Kannada
KARNATAKA
575006
India |
| Phone |
9483056500 |
| Fax |
|
| Email |
spoorthi.mchpmlr2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Audiology and Speech Language Pathology, Kasturba Medical College, Mangalore |
|
|
Primary Sponsor
|
| Name |
Spoorthi G N |
| Address |
Department of Audiology and Speech Language Pathology, Kasturba Medical College, Bejai Campus, Mangalore - 575004 |
| Type of Sponsor |
Private 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 |
| Spoorthi G N |
Kastruba Medical College, Mangalore |
Department of Audiology and Speech Language Pathology, Kasturba Medical College, Bejai Campus, Mangalore - 575004
Dakshina Kannada
KARNATAKA |
9483056500
spoorthi.mchpmlr2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H838||Other specified diseases of innerear, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Audiological rehabilitation |
Providing informational counselling, personal adjustment counselling and perceptual training for adults with hearing loss. The total duration of the intervention will be 10 sessions, with each session lasting for about 45 minutes. |
| Comparator Agent |
Baseline scores |
Baseline score obtained from the following scales:
1.Hearing Handicap Questionnaire
2.Fatigue Assessment Scale
3.Effort Assessment Scale
4.Communication Profile for Hearing Impaired
5.Participation Scale (P-Scale)
6.Assessment of Quality of Life – 4 Dimensions |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Kannada speaking individuals with acquired bilateral hearing loss [four frequency pure tone average (500Hz, 1000Hz, 2000Hz and 4000Hz) between 26 dB HL and 90 dB HL] within the age of 40 - 65 years
2. At least “good†proficiency in Language Experience and Proficiency Questionnaire (LEAP-Q) for reading and speaking proficiency in Kannada
3. Individuals with sensorineural or mixed hearing loss
4. Speech identification scores proportional to pure tone audiometry
5. Aided audiogram at least three frequencies within speech spectrum
6. At least threesix months of experience in using hearing aids, preferably unilateral
7. Self-reported hearing aid use of 4-6 hours daily
8. Montreal Cognitive Assessment (MoCA) scores between 23 to 26
|
|
| ExclusionCriteria |
| Details |
1. Individuals with congenital hearing loss, unilateral hearing loss, conductive hearing loss, or profound degree of hearing loss
2. Individuals who cannot read properly due to vision problems
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Hearing related quality of life
2. General quality of life
3. Communication profile
4. Listening effort
5. ICF activity and participation domains
6. General fatigue |
Baseline, two weeks post rehabilitation, two months post rehabilitation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Listening effort |
Baseline, two weeks post rehabilitation, two months post rehabilitation |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/06/2024 |
| 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="3"
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
|
The aim of the study is to develop a short-term aural rehabilitation module for adults with hearing loss and their significant others in Kannada and validate it. The objectives are to 1. (1) To develop a short-term aural rehabilitation module in Kannada for adults with acquired hearing loss and their significant others. 2. (2) To validate the developed aural rehabilitation module in Kannada for adults with acquired hearing loss and their significant others. It is hypothesized that the developed aural rehabilitation module will improve various aspects of quality of life of individuals with hearing loss and their significant others. |