The Effect of Extremely Low Frequency Electromagnetic Field Device Improving Sleep and Stress

Stress Clinical Trial

Official title:

The Effect of Extremely Low Frequency Electromagnetic Field Device Improving Sleep Quality and Stress

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04737434
• Other study ID #: N202006078
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 31, 2021
• Est. completion date: January 25, 2023

Study information

• Verified date: February 2021
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to explore the effects of extremely low frequency electromagnetic waves on improving stress and sleep quality. Experimental studies, pre- and post-test double-blind crossover tests are adopted. The selected subjects include: patients in the sleep center of the Taipei Medical University Hospital and the Department of Nursing and Bachelor of Taipei Medical University There are about 100 students in the post-nursing department. They are randomly assigned to groups A and B using a computer. The experiment period is two weeks. The two groups will take a pre-questionnaire test in the afternoon of the first day of the experiment and wear wearable bracelets. Group A first After getting the device with low-frequency electromagnetic field, group B first got the device without low-frequency electromagnetic field. The appearance of the two is the same. The bracelet is worn from the afternoon of the first day to the afternoon of the fourth day, a total of three days, and the device is withdrawn at the end of the first stage The two groups exchanged, repeat the steps to complete the second stage, after the end of the post-test, the two groups plug in the device half an hour before going to bed every day, and put it on the bedside table about 20cm away from the head, and then turn off the device after getting up. The research tools are basic attribute questionnaires, sleep quality scales, sleep diaries, smart care VIP bracelets, and EEG. Among them, the wearable bracelet can monitor the stress index, fatigue index, calories burned, and walking steps. Then SPSS 22.0 software is used for data file building and statistical analysis. The data is analyzed by descriptive statistics and inferential statistics. The expected result is that the experimental group and the control group have significant differences in reducing stress and improving sleep quality, which can relieve stress and improve sleep quality.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: January 25, 2023
• Est. primary completion date: January 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

Inclusion Criteria:

• under 20 years old,great mental health,BMI is between 18.5~24(normal range).

Exclusion Criteria:

• Cognitive disturbance, confusion, pregnancy, alcohol and caffeine addiction.

Related Conditions & MeSH terms

• Extremely Low Frequency Electromagnetic Field Device
• Fatigue
• Schumann Resonance
• Sleep Quality
• Stress

Intervention

Device:
• Extremely low frequency electromagnetic field device
with extremely low frequency electromagnetic wave deliver or not to participants during sleep.
• electromagnetic field with no wave
electromagnetic field with no wave

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	Taipei county

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sleep quality	Questionnaire with PSQI(Pittsburgh Sleep Quality Index)	Baseline
Primary	sleep quality	Questionnaire with PSQI(Pittsburgh Sleep Quality Index)	2 weeks
Secondary	stress level	Questionnaire with Perceived Stress Scale	Baseline
Secondary	stress level	Questionnaire with Perceived Stress Scale	2 weeks
Secondary	fatigue levels	Questionnaire with VAS(Visual analogue scale) for fatigue level	Baseline
Secondary	fatigue levels	Questionnaire with VAS(Visual analogue scale) for fatigue level	2 weeks
Secondary	HRV(Heart rate variability) level	Device measure including heart rate variability index, heart rate, etc.	Baseline
Secondary	HRV(Heart rate variability) level	Device measure including heart rate variability index, heart rate, etc.	2 weeks
Secondary	EEG (Electroencephalography) power	a small portable EEG Device measure record including a, ß, ?, d wave and change style and time.	Baseline
Secondary	EEG (Electroencephalography) power	a small portable EEG Device measure record including a, ß, ?, d wave and change style and time.	2 weeks