NCT04737434

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worn from the afternoon of the first day to the afternoon of the fourth day, a total of three days, and the device is withdrawn at the end of the first stage The two groups exchanged, repeat the steps to complete the second stage, after the end of the post-test, the two groups plug in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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

January 31, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2023

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

January 7, 2021

Last Update Submit

February 22, 2021

Conditions

StressSleep QualityFatigueExtremely Low Frequency Electromagnetic Field DeviceSchumann Resonance

Keywords

extremely low frequency electromagnetic field deviceStresssleep qualityfatigueHRVLow Energy Emission TherapySchumann Resonance

Outcome Measures

Primary Outcomes (2)

  • sleep quality

    Questionnaire with PSQI(Pittsburgh Sleep Quality Index)

    Baseline

  • sleep quality

    Questionnaire with PSQI(Pittsburgh Sleep Quality Index)

    2 weeks

Secondary Outcomes (8)

  • stress level

    Baseline

  • stress level

    2 weeks

  • fatigue levels

    Baseline

  • fatigue levels

    2 weeks

  • HRV(Heart rate variability) level

    Baseline

  • +3 more secondary outcomes

Study Arms (2)

Extremely low frequency electromagnetic field device

EXPERIMENTAL

with extremely low frequency electromagnetic wave

Device: Extremely low frequency electromagnetic field device

electromagnetic field with no wave

PLACEBO COMPARATOR

electromagnetic field with no wave

Device: electromagnetic field with no wave

Interventions

Extremely low frequency electromagnetic field deviceDEVICE

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

Extremely low frequency electromagnetic field device
electromagnetic field with no waveDEVICE

electromagnetic field with no wave

electromagnetic field with no wave

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei County, 110, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersFatigue

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tsai-Wei Huang, PhD

    Taipei Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 7, 2021

First Posted

February 3, 2021

Study Start

January 31, 2021

Primary Completion

January 25, 2023

Study Completion

January 25, 2023

Last Updated

February 24, 2021

Record last verified: 2021-02

Locations

TW(1)