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

Primary Purpose

Stress, Sleep Quality, Fatigue

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Extremely low frequency electromagnetic field device
electromagnetic field with no wave
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stress focused on measuring extremely low frequency electromagnetic field device, Stress, sleep quality, fatigue, HRV, Low Energy Emission Therapy, Schumann Resonance

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Taipei Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Extremely low frequency electromagnetic field device

electromagnetic field with no wave

Arm Description

with extremely low frequency electromagnetic wave

electromagnetic field with no wave

Outcomes

Primary Outcome Measures

sleep quality
Questionnaire with PSQI(Pittsburgh Sleep Quality Index)
sleep quality
Questionnaire with PSQI(Pittsburgh Sleep Quality Index)

Secondary Outcome Measures

stress level
Questionnaire with Perceived Stress Scale
stress level
Questionnaire with Perceived Stress Scale
fatigue levels
Questionnaire with VAS(Visual analogue scale) for fatigue level
fatigue levels
Questionnaire with VAS(Visual analogue scale) for fatigue level
HRV(Heart rate variability) level
Device measure including heart rate variability index, heart rate, etc.
HRV(Heart rate variability) level
Device measure including heart rate variability index, heart rate, etc.
EEG (Electroencephalography) power
a small portable EEG Device measure record including α, β, θ, δ wave and change style and time.
EEG (Electroencephalography) power
a small portable EEG Device measure record including α, β, θ, δ wave and change style and time.

Full Information

First Posted
January 7, 2021
Last Updated
February 22, 2021
Sponsor
Taipei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04737434
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 31, 2021 (Actual)
Primary Completion Date
January 25, 2023 (Anticipated)
Study Completion Date
January 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Extremely low frequency electromagnetic field device
Arm Type
Experimental
Arm Description
with extremely low frequency electromagnetic wave
Arm Title
electromagnetic field with no wave
Arm Type
Placebo Comparator
Arm Description
electromagnetic field with no wave
Intervention Type
Device
Intervention Name(s)
Extremely low frequency electromagnetic field device
Intervention Description
with extremely low frequency electromagnetic wave deliver or not to participants during sleep.
Intervention Type
Device
Intervention Name(s)
electromagnetic field with no wave
Intervention Description
electromagnetic field with no wave
Primary Outcome Measure Information:
Title
sleep quality
Description
Questionnaire with PSQI(Pittsburgh Sleep Quality Index)
Time Frame
Baseline
Title
sleep quality
Description
Questionnaire with PSQI(Pittsburgh Sleep Quality Index)
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
stress level
Description
Questionnaire with Perceived Stress Scale
Time Frame
Baseline
Title
stress level
Description
Questionnaire with Perceived Stress Scale
Time Frame
2 weeks
Title
fatigue levels
Description
Questionnaire with VAS(Visual analogue scale) for fatigue level
Time Frame
Baseline
Title
fatigue levels
Description
Questionnaire with VAS(Visual analogue scale) for fatigue level
Time Frame
2 weeks
Title
HRV(Heart rate variability) level
Description
Device measure including heart rate variability index, heart rate, etc.
Time Frame
Baseline
Title
HRV(Heart rate variability) level
Description
Device measure including heart rate variability index, heart rate, etc.
Time Frame
2 weeks
Title
EEG (Electroencephalography) power
Description
a small portable EEG Device measure record including α, β, θ, δ wave and change style and time.
Time Frame
Baseline
Title
EEG (Electroencephalography) power
Description
a small portable EEG Device measure record including α, β, θ, δ wave and change style and time.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsai-Wei Huang, PhD
Organizational Affiliation
Taipei Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Taipei Medical University
City
Taipei county
ZIP/Postal Code
110
Country
Taiwan

12. IPD Sharing Statement

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

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