FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 
Close