CTRI

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CTRI Number

CTRI/2023/06/053972 [Registered on: 16/06/2023] Trial Registered Prospectively

Last Modified On:

15/06/2023

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Single Arm Study

Public Title of Study

This project will assess students Stress levels and Sleep quality using both subjective and objective methods that evolved during Emergency Remote Learning(new teaching learning pedagogy that evolved post COVID-19) using various machine learning Techniques

Scientific Title of Study

Multi-Modal Assessment of Studentâ€™s Stress and Sleep Affecting Academic Performance During Emergency Remote Learning Using Machine Learning Techniques

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Sharisha Shanbhog M
Designation	Research Scholar
Affiliation	Manipal Institute of Technology
Address	Department of Biomedical engineering, Manipal Institute of Technology(MIT), Manipal Udupi KARNATAKA 576104 India
Phone
Fax
Email	shanbhg@yahoo.com

Details of Contact Person
Scientific Query

Name	Dr Jeevan M
Designation	Associate Professor and Guide
Affiliation	Manipal Institute of Technology,Manipal
Address	Department of Biomedical Engineering Manipal Institute of technology(MIT) Manipal Department of Biomedical Engineering, Manipal Institute of Technology, Manipal 576104 Udupi KARNATAKA 576104 India
Phone
Fax
Email	jeevan.m@manipal.edu

Details of Contact Person
Public Query

Name	Dr Jeevan M
Designation	Associate Professor and Guide
Affiliation	Manipal Institute of Technology,Manipal
Address	Department of Biomedical Engineering Manipal Institute of technology(MIT) Manipal Department of Biomedical Engineering, Manipal Institute of Technology,Manipal,576104 Udupi KARNATAKA 576104 India
Phone
Fax
Email	jeevan.m@manipal.edu

Source of Monetary or Material Support

Manipal Institute of Technology(MIT),Manipal

Primary Sponsor

Name	Sharisha Shanbhog M
Address	Research Scholar, Department of Biomedical Engineering, Manipal Institute of Technology(MIT), Manipal 576104
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
Sharisha Shanbhog M	Manipal Institute of Technology	Manipal Institute of Technology(MIT) Manipal 576104 Udupi KARNATAKA	7073111448 shanbhg@yahoo.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

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Healthy Subjects

Intervention / Comparator Agent

Type

Name

Details

Inclusion Criteria

Age From	19.00 Year(s)
Age To	23.00 Year(s)
Gender	Both
Details	1)This study is intended to administer students who have experienced both classroom learning and ERL during their B.tech course. 2)Hence this study is intended to include 3rd and 4th year B. tech students.

ExclusionCriteria

Details

Based on inclusion criteria, this study excludes 1st and 2nd year B.tech students.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome

TimePoints

1)This study is aimed at analyzing different stressors that would have evolved during ERL and
has largely contributed to their mental stress and overall sleep quality which together has an
impact on their overall academic performance.

2) A validated questionnaire tool will be used to assess different stressors which focuses on students environment their perception of stress and different factors with respect to instruction medium (ERL).

3)Physiological signals like ECG HR ST Speech and Voice from publicly available datasets will be used to measure the persons stress levels and categorize them on further processing of data.

4)This study classifys the stress as Low High and Moderate levels of the subjects who either has Good or Bad quality sleep which has contributed for his/her Good Average or Bad overall academic performance.

4 years

Secondary Outcome

Outcome	TimePoints
This study classifies the stress as Low High and Moderate levels of the subjects who either has Good or Bad quality sleep which has contributed for his/her Good Average or Bad overall academic performance.	5 years

Target Sample Size

Total Sample Size="2500"
Sample Size from India="2500"
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)

01/07/2023

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)

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)?

Response - NO

Brief Summary

Academics has said to contribute mental stress among students and there is a rise in mental illness post pandemic which has adverse effects over the sleep quality and the overall academic performance of the students. This multimodal model is designed to make accurate predictions of stress levels and sleep quality which can be employed by an clinical psychologist as an assistant both during physical or virtual assessment of subjects