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

February 22, 2021 updated by: Tsai-Wei Huang, Taipei Medical University

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

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worn from the afternoon of the first day to the afternoon of the fourth day, a total of three days, and the device is withdrawn at the end of the first stage The two groups exchanged, repeat the steps to complete the second stage, after the end of the post-test, the two groups plug in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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei county, Taiwan, 110
        • Taipei Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Extremely low frequency electromagnetic field device
with extremely low frequency electromagnetic wave
Device: Extremely low frequency electromagnetic field device
with extremely low frequency electromagnetic wave deliver or not to participants during sleep.
PLACEBO_COMPARATOR: electromagnetic field with no wave
Device: electromagnetic field with no wave
electromagnetic field with no wave

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sleep quality
Time Frame: Baseline
Questionnaire with PSQI(Pittsburgh Sleep Quality Index)
Baseline
sleep quality
Time Frame: 2 weeks
Questionnaire with PSQI(Pittsburgh Sleep Quality Index)
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stress level
Time Frame: Baseline
Questionnaire with Perceived Stress Scale
Baseline
stress level
Time Frame: 2 weeks
Questionnaire with Perceived Stress Scale
2 weeks
fatigue levels
Time Frame: Baseline
Questionnaire with VAS(Visual analogue scale) for fatigue level
Baseline
fatigue levels
Time Frame: 2 weeks
Questionnaire with VAS(Visual analogue scale) for fatigue level
2 weeks
HRV(Heart rate variability) level
Time Frame: Baseline
Device measure including heart rate variability index, heart rate, etc.
Baseline
HRV(Heart rate variability) level
Time Frame: 2 weeks
Device measure including heart rate variability index, heart rate, etc.
2 weeks
EEG (Electroencephalography) power
Time Frame: Baseline
a small portable EEG Device measure record including α, β, θ, δ wave and change style and time.
Baseline
EEG (Electroencephalography) power
Time Frame: 2 weeks
a small portable EEG Device measure record including α, β, θ, δ wave and change style and time.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 31, 2021

Primary Completion (ANTICIPATED)

January 25, 2023

Study Completion (ANTICIPATED)

January 25, 2023

Study Registration Dates

First Submitted

January 7, 2021

First Submitted That Met QC Criteria

January 31, 2021

First Posted (ACTUAL)

February 3, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 24, 2021

Last Update Submitted That Met QC Criteria

February 22, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N202006078

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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