Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 10:37 AM
Study NCT ID:
NCT04737434
Status:
UNKNOWN
Last Update Posted:
2021-02-24
First Post:
2021-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Extremely Low Frequency Electromagnetic Field Device Improving Sleep and Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2023-01-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-22', 'studyFirstSubmitDate': '2021-01-07', 'studyFirstSubmitQcDate': '2021-01-31', 'lastUpdatePostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sleep quality', 'timeFrame': 'Baseline', 'description': 'Questionnaire with PSQI(Pittsburgh Sleep Quality Index)'}, {'measure': 'sleep quality', 'timeFrame': '2 weeks', 'description': 'Questionnaire with PSQI(Pittsburgh Sleep Quality Index)'}], 'secondaryOutcomes': [{'measure': 'stress level', 'timeFrame': 'Baseline', 'description': 'Questionnaire with Perceived Stress Scale'}, {'measure': 'stress level', 'timeFrame': '2 weeks', 'description': 'Questionnaire with Perceived Stress Scale'}, {'measure': 'fatigue levels', 'timeFrame': 'Baseline', 'description': 'Questionnaire with VAS(Visual analogue scale) for fatigue level'}, {'measure': 'fatigue levels', 'timeFrame': '2 weeks', 'description': 'Questionnaire with VAS(Visual analogue scale) for fatigue level'}, {'measure': 'HRV(Heart rate variability) level', 'timeFrame': 'Baseline', 'description': 'Device measure including heart rate variability index, heart rate, etc.'}, {'measure': 'HRV(Heart rate variability) level', 'timeFrame': '2 weeks', 'description': 'Device measure including heart rate variability index, heart rate, etc.'}, {'measure': 'EEG (Electroencephalography) power', 'timeFrame': 'Baseline', 'description': 'a small portable EEG Device measure record including α, β, θ, δ wave and change style and time.'}, {'measure': 'EEG (Electroencephalography) power', 'timeFrame': '2 weeks', 'description': 'a small portable EEG Device measure record including α, β, θ, δ wave and change style and time.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['extremely low frequency electromagnetic field device', 'Stress', 'sleep quality', 'fatigue', 'HRV', 'Low Energy Emission Therapy', 'Schumann Resonance'], 'conditions': ['Stress', 'Sleep Quality', 'Fatigue', 'Extremely Low Frequency Electromagnetic Field Device', 'Schumann Resonance']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* under 20 years old,great mental health,BMI is between 18.5\\~24(normal range).\n\nExclusion Criteria:\n\n* Cognitive disturbance, confusion, pregnancy, alcohol and caffeine addiction.'}, 'identificationModule': {'nctId': 'NCT04737434', 'briefTitle': 'The Effect of Extremely Low Frequency Electromagnetic Field Device Improving Sleep and Stress', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University'}, 'officialTitle': 'The Effect of Extremely Low Frequency Electromagnetic Field Device Improving Sleep Quality and Stress', 'orgStudyIdInfo': {'id': 'N202006078'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Extremely low frequency electromagnetic field device', 'description': 'with extremely low frequency electromagnetic wave', 'interventionNames': ['Device: Extremely low frequency electromagnetic field device']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'electromagnetic field with no wave', 'description': 'electromagnetic field with no wave', 'interventionNames': ['Device: electromagnetic field with no wave']}], 'interventions': [{'name': 'Extremely low frequency electromagnetic field device', 'type': 'DEVICE', 'description': 'with extremely low frequency electromagnetic wave deliver or not to participants during sleep.', 'armGroupLabels': ['Extremely low frequency electromagnetic field device']}, {'name': 'electromagnetic field with no wave', 'type': 'DEVICE', 'description': 'electromagnetic field with no wave', 'armGroupLabels': ['electromagnetic field with no wave']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110', 'city': 'Taipei County', 'country': 'Taiwan', 'facility': 'Taipei Medical University'}], 'overallOfficials': [{'name': 'Tsai-Wei Huang, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Taipei Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Tsai-Wei Huang', 'investigatorAffiliation': 'Taipei Medical University'}}}}