| CTRI Number |
CTRI/2018/07/015099 [Registered on: 27/07/2018] Trial Registered Prospectively |
| Last Modified On: |
25/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Auditory Training] |
| Study Design |
Other |
|
Public Title of Study
|
Therapeutic Influence On Acceptable Noise Level Scores In Elderly Persons With Hearing Impairment. |
|
Scientific Title of Study
|
Influence Of Auditory Training On Acceptable Noise Level Scores In Elderly Persons With Hearing Impairment. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Megha K |
| Designation |
Student |
| Affiliation |
School Of Allied Health Science, Manipal. |
| Address |
D/O K Manjunath Nakshathri
Kunjagudde, Ambalpady post-
Udupi
Department of Speech and Hearing,
SOAHS, MAHE.
Udupi
KARNATAKA
576103
India |
| Phone |
7411190964 |
| Fax |
|
| Email |
meghanakshathri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kishan M M |
| Designation |
Associate Professor |
| Affiliation |
School Of Allied Health Science, Manipal. |
| Address |
Department of Speech and Hearing,
SOAHS, MAHE.Manipal.
Department of Speech and Hearing,
SOAHS, MAHE.Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9845141575 |
| Fax |
|
| Email |
kishan.m@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Megha K |
| Designation |
Student |
| Affiliation |
School Of Allied Health Science, Manipal. |
| Address |
D/O K Manjunath Nakshathri
Kunjagudde, Ambalpady post-
Udupi
Department of Speech and Hearing,
SOAHS, MAHE.
Udupi
KARNATAKA
576103
India |
| Phone |
7411190964 |
| Fax |
|
| Email |
meghanakshathri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Speech and Hearing, School of Allied Health Sciences, Manipal. |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 |
| Megha K |
School of Allied Health Sciences |
Department of speech and Hearing
Udupi
KARNATAKA |
7411190964
meghanakshathri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital- Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Elderly Persons With Hearing Imapirment, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Auditory training |
Auditory training will be given for 12 sessions and each session will be taken for about 20 minutes. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1)Individuals with B/L sensorineural hearing loss from mild to moderate severe degree of loss
2)Normal middle ear function
3)Individuals without neurological, motor, mental changes or associated syndromes that may hinder understanding and realization of the proposed tasks (MOCA will be administered to screen cognitive ability)
|
|
| ExclusionCriteria |
| Details |
Participants who are not meeting the inclusion criteria will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Acceptable Noise Level Scores in dB |
After two weeks from the initiation of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Acceptable Noise Level Scores in dB during intermediate evaluation |
After 1 week from the initiation of intervention |
|
|
Target Sample Size
|
Total Sample Size="69"
Sample Size from India="69"
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 3 |
|
Date of First Enrollment (India)
|
16/08/2018 |
| 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="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
|
Geriatric
population with age related hearing loss show poor scores of ANL and SPIN when
compared to adults, though all features against hearing aid fitting to hearing
aid, still hearing aids will be denied by this group, since it further ÂÂÂÂdeteriorates
their performance.
Hence,
subjecting these population to auditory training (listening skills in
background noise) will improve their ability and they can become effective
hearing aid user.Hence
the research work is taken to study the Influence of Auditory Training on
Acceptable Noise Level scores in elderly persons with hearing impairment
|