| CTRI Number |
CTRI/2019/01/017073 [Registered on: 14/01/2019] Trial Registered Prospectively |
| Last Modified On: |
18/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of cognitive training through auditory modality in elderly people with mild cognitive impairment |
|
Scientific Title of Study
|
Efficacy of Auditory-Based Cognitive Training on memory functions in elderly persons with mild cognitive impairment |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priya |
| Designation |
Assistant Professor |
| Affiliation |
School of Allied Health Sciences, Manipal University |
| Address |
Department of Speech and Hearing, School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
09480041575 |
| Fax |
|
| Email |
priya.g@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr GopeeKrishnan |
| Designation |
Associate Professor |
| Affiliation |
School of Allied Health Sciences, Manipal University |
| Address |
Department of Speech and Hearing, School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
09036459815 |
| Fax |
|
| Email |
krishnan.g@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Priya |
| Designation |
Assistant Professor |
| Affiliation |
School of Allied Health Sciences, Manipal University |
| Address |
Department of Speech and Hearing, School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
09480041575 |
| Fax |
|
| Email |
priya.g@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ms Priya G |
| Address |
Department of Speech and Hearing, School of Allied Health Sciences,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 |
| Priya |
SOAHS, MAHE |
Department of Speech and Hearing, School of Allied Health Sciences,MAHE.
Udupi
KARNATAKA |
9480041575
priya.g@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Registration No. ECR/146/Inst/KA/2013/RR-16) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F068||Other specified mental disorders due to known physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2 arms Experimental group and Control group |
Persons with Mild Cognitive impairment will given auditory based cognitive training using a software. Experimental group will receive training whereas control group will be under observation.Response accuracy scores of various cognitive tasks and sum scores of FAQ will be obtained for both the arms. Scores obtained will be compared for both the arms |
| Intervention |
Auditory Based Cognitive Training Using a software |
Auditory Based Cognitive Training software has various tasks to improve working memory. |
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Normal or corrected to normal vision
Hearing acuity (Air Conduction thresholds <25dBHL up to 1KHz and less than or equal to 40dBHL from 2 to 8KHz)
Able to read and write Kannada
|
|
| ExclusionCriteria |
| Details |
Presence of other obvious neurological/psychological disorders
Presence or history of dementia, depression and amnesia.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome measure of this study will be the response accuracy score for various tasks in cognitive test battery which tests memory in detail |
The primary outcome measure of this study will be assessed thrice,baseline assessment, post intervention and one month post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome measure will be the sum scores of the Functional Activities Questionnaire |
Sum scores |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
01/06/2019 |
| 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="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The participants of this study will
include elderly people with mild cognitive impairment in the age range of 55 to
70 years. A detailed case history will be taken for each participants before
screening them for mild cognitive impairment. The participants swill be screened using Mini Mental State Examination (MMSE) ,Geriatric Depression Scale and Mini Cog Test. They should not be
undergoing any form of treatment during the study process. All the participants
will undergo a set of auditory tests other than routine audiological evaluation
to assess their central auditory processing ability. Elderly people who come to
Department of Speech and Hearing, SOAHS for hearing evaluation will be
considered for the study. Also participants will be recruited from geriatric
hearing screening camps. Apart from this, the participants will also be
included from the community. Participants for this will be randomized based on simple randomization method of picking
chits and based on that they will be assigned to either
Group I or Group II. Following the
eligibility criteria and randomization of the participants, baseline assessment
of the cognitive functions, specifically working memory will be carried out for
all the participants including group I and group II. For assessing the
cognitive functions specifically memory in detail, NIMHANS Neuropsychological Battery
for elderly (NNB-E) will be used. Functional Activities Questionnaire which consists of ten questions
will also be administered along with the cognitive assessment. The cognitive
assessment will be carried out in the Department of Clinical Psychology, SOAHS. |