| CTRI Number |
CTRI/2022/11/047174 [Registered on: 10/11/2022] Trial Registered Prospectively |
| Last Modified On: |
08/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Heraing aids ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Listening difficulty and hearing aid signal processing
|
|
Scientific Title of Study
|
Assessment of self reported listening effort and working memory in channelfree and multi channel hearing aids.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mariam Elishba |
| Designation |
PG student |
| Affiliation |
Manipal College of health professions |
| Address |
Department of speech and hearing Manipal college of health professions(MCHP),MAHE,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9946364508 |
| Fax |
|
| Email |
mariam.elishba1@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kishan M M |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of health professions |
| Address |
Department of speech and hearing Manipal college of health professions(MCHP),MAHE,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845141575 |
| Fax |
|
| Email |
kishan.m@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mariam Elishba |
| Designation |
PG student |
| Affiliation |
Manipal College of health professions |
| Address |
Department of speech and hearing Manipal college of health professions(MCHP),MAHE,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9946364508 |
| Fax |
|
| Email |
mariam.elishba1@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Speech and Hearing,MCHP
Kasturba Medical College,Manipal |
|
|
Primary Sponsor
|
| Name |
Mariam Elishba |
| Address |
Department of speech and hearing ,MCHP, MAHE, Manipal |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mariam Elishba |
Manipal college of health professions |
Department of speech and hearing, Manipal college of health professions, MAHE,Manipal
Udupi
KARNATAKA |
9946364508
mariam.elishba1@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Bilateral Sensorineural Hearing Loss |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Bilateral sensorineural hearing loss
Degree of hearing loss - mild to moderately severe
Normal tympanogram
|
|
| ExclusionCriteria |
| Details |
Neurological conditions that influence hearing aid and working memory function.
Severe cognitive deficits that affect working memory
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| SWIR scores ( in percentage ) |
30-45 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SPIN test scores in percentage
SSQ response in mean score
APHAB response in mean score
|
1 week |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
14/11/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
AIM : To
study the self-reported listening effort and working memory outcome measures of
channelfree hearing aid. OBJECTIVE: 1)To
assess the listening effort using self-reported measures using SSQ ( Speech , Spatial and Qualities of hearing scale ), and APHAB(Abbreviated Profile of hearing aid benefit )
2)
To determine the sentence-final word identification and recall with noise
reduction ON and OFF condition NEED : Faster
signal processing, phonemic compression and noise reduction of channel free hearing aid should influence or
interact with the individuals cognitive process and reduce listing effort when compared multichannel signal processing technology. Hence there arises a need. PROCEDURE: Participants will be recruited from Audiology OPD after basic audiological evaluation . Participants fulfilling the inclusion criteria will undergo hearing aid trail with multichannel and channel free hearing aid. MOCA , SPIN TEST ,SWIR ,APHAB , SSQ ,RAT scale will be administered with multichannel and channel free hearing aid with noise reduction feature on and off condition.
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