Study of Evoked Emotional Responses

NCT04044261 | Completed

• 1 other identifier: EMO-001 Phase 0
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Mental health and emotional awareness are a crucial need of the time. Changing lifestyles, stress, and anxiety are seen more commonly and affect many adults in the United States and other countries. Primary aim of this study is to identify the bio-physiological data that is corrected emotions of a person in support of EMO-001 device research. This study will induce different emotions in the test subjects and collect physiological response signals using Photo Plethysmography (PPG), Galvanic Skin Response (GSR) and Electrocardiogram (ECG) sensors. The sensor data is digitally recorded in a storage bank. The data will be subsequently used to develop supervised and unsupervised classification algorithms. Emotional states considered in this study are Anger, Amusement, Neutral, Disgust, Sadness, Scared, Surprise and Thrill. These emotions were induced by showing video clips of three to five minutes to the subjects. For each emotion three clips were shown to each subject. Video clips are sourced from movies, TV shows, and real-life recordings. Subjects evaluated each video clip and classify them into perceived emotional ratings. Data is processed through a series of filter and transformation methods. The transformed data is used to develop and calibrate algorithms that can identify emotions.

Conditions

Emotion, Expressed

Keywords

Emotional Response

Outcome Measures

Primary Outcomes (3)

• ECG V1

  Electrocardiogram V1-lead only

  Two hours

• SpO2

  Blood oxygen concentration using photoplethysmography

  Two hours

• GSR

  Galvanic skin response

  Two hours

Study Arms (1)

Study Arm

EXPERIMENTAL

Single open-label study arm. All participants are enrolled into this arm.

Procedure: Emotion induction using video

Interventions

Emotion induction using video PROCEDURE

Emotions are induced in the test subjects using videos in Hindi and English. Each subject is shown three video clips for each of the emotions.

Study Arm

Eligibility Criteria

• Age: 18 Years - 33 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Bachelor's degree

You may not qualify if:

• History of neurological disorders
• History of psychological disorders
• Current unemployment
• Major surgery in the past two years
• Chronic disease prescriptions

Sponsors & Collaborators

• Monsoon Design Studio LLC: lead
• Healthark Wellness Solutions LLP: collaborator

Study Sites (1)

Healthark Wellness Solutions LLP

Ahmedabad, Gujarat, 380015, India

Location

Study Officials

• Purav Gandhi, MBBS

  Healthark Wellness Solutions LLP

  PRINCIPAL INVESTIGATOR

• Anshu Shah, PhD

  Healthark Wellness Solutions LLP

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 5, 2019
• Study Start: November 1, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: August 5, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)