NCT01708031

Brief Summary

Computerized Mental Arithmetic Task Based Human Stress Level Detection Using Physiological Signal The objective of this study is to induce and measure the human stress level through computerized mental arithmetic task and multiple physiological signals (ECG, EMG, GSR, and skin temperature). Studies suggested that mental arithmetic task is one of the efficient stimuli to induce the stress. Hence, this mental arithmetic task protocol has been improved in to computerized version. The protocol will be tested with normal subjects and multiple physiological signals will be acquired simultaneously. The questionnaire about the subject experience will be obtained in order to strengthen the stress induction. The normal volunteer subjects will be invited for the participation this study. The physiological signal will be analyzed using suitable algorithm based on the characteristics of each signals. The multiple signal based stress level assessment system will be developed by training and testing the acquired data.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 10, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 16, 2012

Status Verified

October 1, 2012

Enrollment Period

1.5 years

First QC Date

October 10, 2012

Last Update Submit

October 15, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Stress levels assesment desinged based on the physiological signal acquired from the various subject by using MAT protocal.

    Selection of physiological signals The following four physiological signal will be acquired based on the strong clinical evidence, Non-intrusive measurement, and futuristic to develop the real time detection system using compact electronics that to reduce the obtrusive of the human in real time activities such as in job, sports application. Electromyogram Galvanic skin response Skin temperature

    90 minutes

Study Arms (1)

stress inducing task

EXPERIMENTAL

Normal subjects without history medication presently will be participated. Stress induced through stress inducing task (mental arithmetic task), the physiological signals collected before and during the task simultaneously. All the subjects will be participating only once in this MAT based study. Because, the stress will not be possible to induce when the subject is more familiar with the stress inducing task.

Other: physiological signals

Interventions

Also known as: ECG, EMG, GSR, Skin temperature, EEG, BP
stress inducing task

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • \- no histroy of disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unimap

Kangar, Perlis, 02600, Malaysia

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

Skin Temperature

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Body TemperaturePhysiological PhenomenaSkin Physiological PhenomenaIntegumentary System Physiological Phenomena

Study Officials

  • Sazali Yaacob, PhD

    Unimap

    PRINCIPAL INVESTIGATOR
  • Murugappan M, PhD

    Unimap

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr

Study Record Dates

First Submitted

October 10, 2012

First Posted

October 16, 2012

Study Start

October 1, 2011

Primary Completion

April 1, 2013

Study Completion

December 1, 2014

Last Updated

October 16, 2012

Record last verified: 2012-10

Locations