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StressNCT04737434

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

A study testing Extremely low frequency electromagnetic field device and electromagnetic field with no wave in people with Stress and Sleep Quality, run by Taipei Medical University at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Stress, Sleep Quality, Fatigue
What is being tested?
Extremely low frequency electromagnetic field device and electromagnetic field with no wave
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteTaiwan
Study dates
31 Jan 2021to 25 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Taipei Medical University

    Taipei County, 110

Other trials in Taiwan

About this study

Official title: 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.

Being tested
Extremely low frequency electromagnetic field device, electromagnetic field with no wave
Keywords
extremely low frequency electromagnetic field device, Stress, sleep quality, fatigue, HRV, Low Energy Emission Therapy, Schumann Resonance
Medical subject headings
Sleep Initiation and Maintenance Disorders, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Extremely low frequency electromagnetic field deviceDevice

    with extremely low frequency electromagnetic wave deliver or not to participants during sleep.

  • electromagnetic field with no waveDevice

    electromagnetic field with no wave

Study groups in NCT04737434
Study groupRoleWhat they receive
Extremely low frequency electromagnetic field deviceExperimentalwith extremely low frequency electromagnetic wave
Receives: Device: Extremely low frequency electromagnetic field device
electromagnetic field with no wavePlacebo comparatorelectromagnetic field with no wave
Receives: Device: electromagnetic field with no wave

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. sleep quality

    Questionnaire with PSQI(Pittsburgh Sleep Quality Index)

    Measured: Baseline

  2. sleep quality

    Questionnaire with PSQI(Pittsburgh Sleep Quality Index)

    Measured: 2 weeks

Secondary outcomes (8)

  1. stress level

    Questionnaire with Perceived Stress Scale

    Measured: Baseline

  2. stress level

    Questionnaire with Perceived Stress Scale

    Measured: 2 weeks

  3. fatigue levels

    Questionnaire with VAS(Visual analogue scale) for fatigue level

    Measured: Baseline

  4. fatigue levels

    Questionnaire with VAS(Visual analogue scale) for fatigue level

    Measured: 2 weeks

  5. HRV(Heart rate variability) level

    Device measure including heart rate variability index, heart rate, etc.

    Measured: Baseline

  6. HRV(Heart rate variability) level

    Device measure including heart rate variability index, heart rate, etc.

    Measured: 2 weeks

  7. EEG (Electroencephalography) power

    a small portable EEG Device measure record including α, β, θ, δ wave and change style and time.

    Measured: Baseline

  8. EEG (Electroencephalography) power

    a small portable EEG Device measure record including α, β, θ, δ wave and change style and time.

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2021
  2. Study start31 Jan 2021
  3. Primary completion25 Jan 2023 (estimated)
  4. Study completion25 Jan 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04737434
Sponsor's protocol ID
N202006078
Status last verified
Feb 2021
First submitted
7 Jan 2021
Last updated
24 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Extremely low frequency electromagnetic field device and electromagnetic field with no wave in people with Stress and Sleep Quality, run by Taipei Medical University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

sleep quality (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04737434.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.

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