| CTRI Number |
CTRI/2026/03/107063 [Registered on: 30/03/2026] Trial Registered Prospectively |
| Last Modified On: |
27/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
This study aims to understand the relationship between the lifestyle of older adults(smoking,drinking alcohol,physical activity etc)self reported measures(weight,height,hearing loss) which will affect their brain health and brain resilience .
MoCA will be used to assess mental abilities |
|
Scientific Title of Study
|
Exploring the relationship between Cognition, cognitive reserve, and modifiable risk factors for cognitive decline in the elderly. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hiba |
| Designation |
MSc. Audiology Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and hearing , Manipal College of Health Professions , Manipal
Udupi KARNATAKA 576104 India |
| Phone |
8606749049 |
| Fax |
|
| Email |
hiba.mchpmpl2025@learner.manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Hari Prakash P |
| Designation |
Additional Professor |
| Affiliation |
Manipal College of Health Professions, MAHE |
| Address |
Department of Speech and hearing , Manipal College of Health Professions , Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9886135522 |
| Fax |
|
| Email |
hari.prakash@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Hari Prakash P |
| Designation |
Additional Professor |
| Affiliation |
Manipal College of Health Professions, MAHE |
| Address |
Department of Speech and hearing , Manipal College of Health Professions , Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9886135522 |
| Fax |
|
| Email |
hari.prakash@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
HibaSelf |
| Address |
Department of Speech and Hearing , Manipal College of Health Professions ,Madhav nagar ,Manipal , 576104 ,
karnataka , India |
| 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 P |
Kasturba Hospital |
Room no.27 ,2nd floor , Audiology OPD clinic , Mahe Manipal - 576104
Udupi KARNATAKA |
8202922748
hari.prakash@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 -2 (Student research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Cognitive decline |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Capable of providing information regarding their lifestyle habits.
2. Sufficient digital literacy and email access to independently receive, comprehend, and complete
electronic forms.
3. Adequate literacy in the English language to comprehend and fill out the standardized
questionnaires. |
|
| ExclusionCriteria |
| Details |
•Any known significant neurological conditions.
•Significant sensory impairment, which limits the subject from participating/ understanding the instructions of the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the mediating effect of cognitive reserve on the association between modifiable risk factors and cognitive function in elderly.
|
Once at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="76" Sample Size from India="76"
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)
|
10/04/2026 |
| 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="11" 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
|
Aim of the study: To assess the mediating effect of cognitive reserve on the association between modifiable risk factors and cognitive function in elderly. Objective(s) of the study: To evaluate the following modifiable risks factors and their relation with cognition and cognitive reserve: - Physical activity
- Alcohol use
- Smoking habits
- Obesity
- Hearing loss.
Questionnaires administered:i) Mini Montreal Cognitive Assessment ( Mini MoCA) ii) Short Cognitive Reserve Index Questionnaire(s-CRIq) iii) Global Activity Physical Questionnaire (GPAQ) iv) The Alcohol Use Disorders Identification Test (AUDIT) v) Heaviness of Smoking Index(HSI) Self–reported measures: i) Body Mass Index(BMI) ii) Hearing loss iii) Systemic illness Participants will be recruited through a community-based approach. Elderly individuals will be screened and recruited from the general community, including surrounding residential neighborhoods, with a particular focus on areas where older adults are known to gather regularly, such as public parks, community centers, and walking tracks.Potential participants will be approached and provided with detailed information regarding the purpose and procedures of the study. Individuals who express willingness to participate will be requested to voluntarily share their contact details (phone number/email address) for further communication. Electronic versions of the participant information sheet, informed consent form, and study questionnaires will then be sent to them. Informed consent along with demographic details ( Name, Age, and contact number ) will be obtained from all participants after they have been informed about the study details online, ensuring that they understand their participation is voluntary. The use of participants’ contact numbers will be clearly stated in the electronic forms prior to obtaining informed consent. Participants will be informed that their contact details are being collected solely for the purpose of administering test materials and that this process will take approximately 5-10 minutes. Individuals who consented to the study and provided valid responses will be subsequently contacted via telephone calls, and cognitive screening will be conducted by administering Mini-MoCA. q |