Clinical trial NCT04737434: The Effect of Extremely Low Frequency Electromagnetic Field Device Improving Sleep and Stress
Official title: The Effect of Extremely Low Frequency Electromagnetic Field Device Improving Sleep Quality and Stress
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress
Sleep Quality
Fatigue
Extremely Low Frequency Electromagnetic Field Device
Schumann Resonance
Keywords: extremely low frequency electromagnetic field device
Stress
sleep quality
fatigue
HRV
Low Energy Emission Therapy
Schumann Resonance
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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worn from the afternoon of the first day to the afternoon of the fourth day, a total of three days, and the device is withdrawn at the end of the first stage The two groups exchanged, repeat the steps to complete the second stage, after the end of the post-test, the two groups plug in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.


Eligibility criteria: 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.

Primary outcomes:
measure: sleep quality
timeFrame: Baseline
measure: sleep quality
timeFrame: 2 weeks
Secondary outcomes:
measure: stress level
timeFrame: Baseline
measure: stress level
timeFrame: 2 weeks
measure: fatigue levels
timeFrame: Baseline
measure: fatigue levels
timeFrame: 2 weeks
measure: HRV(Heart rate variability) level
timeFrame: Baseline
measure: HRV(Heart rate variability) level
timeFrame: 2 weeks
measure: EEG (Electroencephalography) power
timeFrame: Baseline
measure: EEG (Electroencephalography) power
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Taipei county
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: Tsai-Wei Huang, PhD
role: STUDY_CHAIR
References: