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临床试验/NCT04044261
NCT04044261已完成不适用

Study of Evoked Emotional Responses for Supporting Research of EMO-001 Device Using Photoplethysmography, Galvanic Skin Response, and Electrocardiography

Monsoon Design Studio LLC2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
SpO2

研究概览

简要总结

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.

详细描述

Millions of people are affected by mental health conditions every year. Approximately one in five adults in the U.S. experiences at least one mental illness episode every year. Approximately 16 million people have at least one major depressive episode in one year. Researchers have identified that Millennial age-group is at highest risk of developing anxiety, depression, and thoughts of suicide than any other generation. These conditions are attributed by many reasons like increasing competition, less communication, less real-world attachment, work pressure, etc.

Considering the increasing level of issues related to mental health, compelled to think about understanding emotions and associated health impact. Popular methods of emotion detection are by detecting facial expression but to detect real-time emotion, biophysical signals are the best tool as per literature. Also, by considering the future possibility of product form of EMO-001, emotion detection through bio-signals proved to be the correct approach. The intent of the research is to classify the evoked emotions based on bio-signals in support of the product EMO-001 device using photo plethysmography (PPG), Galvanic Skin Response (GSR) and Electrocardiogram (ECG). Identification of emotions from bio-signals, and development of classification algorithm helps the product to identify the emotional state of the person real-time and eventually helps to track the emotional state and suggest an activity which can lift the emotional well being of a person.

Major six emotions, amusement, sad, disgust, scared, surprised, thrill were considered to collect bio signal. Bio signals for the neutral state were also captured to create a baseline for identifying changes in the bio signals with changing emotions.

To find the gender balance in subjects, a similar ratio of male and female considered. Targeting Millennial age-group for this product, we consider people from the age of 18 to 33 years with a minimum bachelor degree qualification and those who are employed. We considered people who understand English and Hindi are considered as subject as video content were in these languages only.

Exploring different methods of emotion elicitation, an audio visual method was considered for this trial, as it is the most effective methods described in different previous literature and through practical scenario. More than 1,000 Video clips from open platform were seen and analysed for five different emotions. Out of which 100 video (20 per emotion) clips were scrutinized by three level checks, selected video clips were also validated by internal blind check to figure out what exact emotion has been elicited from each video. From these identified clips, different set of clips had been prepared. We could identify that video clips are less effective to elicit the anger; hence interaction method was used for it.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 33 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Bachelor's degree

排除标准

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

研究组 & 干预措施

Study Arm

Experimental

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

干预措施: Emotion induction using video (Procedure)

结局指标

主要结局

SpO2

时间窗: Two hours

Blood oxygen concentration using photoplethysmography

GSR

时间窗: Two hours

Galvanic skin response

ECG V1

时间窗: Two hours

Electrocardiogram V1-lead only

次要结局

未报告次要终点

研究者

发起方
Monsoon Design Studio LLC
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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