Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-04 @ 4:41 PM
Study NCT ID:
NCT02765958
Status:
COMPLETED
Last Update Posted:
2018-02-08
First Post:
2016-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analyze Sleep Stages by Portable ECG Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-07', 'studyFirstSubmitDate': '2016-05-04', 'studyFirstSubmitQcDate': '2016-05-05', 'lastUpdatePostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RR interval changes compared to the report of polysomography', 'timeFrame': '8 hours', 'description': 'The difference of RR interval in healthy subjects and obstructive sleep apnea subjects'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': "Sleep is a fundamental need for human and is associated with the working performance and the disease occurrence. Furthermore, the amount of people with sleep disorder or apnea increased largely. Thus, the analysis of sleep stages and the measurement of sleep quality became more important recently. In clinical settings, the analysis of daily sleep quality depends on actigraphy and sleep log. However, the uses of actigraphy and sleep log are not really convenient for patients. In this trial, the investigators will measure the subjects' ECG signal and movement using a portable ECG device with motion sensor. On the other hand, the sleep stages are also obtained from the current wide-established measurement- polysomnography. The ECG signals, movements, and sleep stages will be analyzed by our algorithm of artificial neural network. Then, the investigators can obtain the preliminary analysis of sleep quality can be obtained by using ECG device with our algorithm. It is helpful for doctors to realize the patent's sleep quality quickly"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'outpatient in chest clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* OSA: OPD OSA patients; Healthy: no OSA\n\nExclusion Criteria:\n\n* heart disease\n* arrhythmia'}, 'identificationModule': {'nctId': 'NCT02765958', 'briefTitle': 'Analyze Sleep Stages by Portable ECG Device', 'organization': {'class': 'OTHER', 'fullName': 'Far Eastern Memorial Hospital'}, 'officialTitle': 'Analyze Sleep Stages by Portable ECG Device', 'orgStudyIdInfo': {'id': 'FEMH-104181-F'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy', 'description': 'subjects without heart disease or arrhythmia, no evidence of obstructive sleep apnea', 'interventionNames': ['Device: portable ECG devise']}, {'label': 'OSA', 'description': 'obstructive sleep apnea', 'interventionNames': ['Device: portable ECG devise']}], 'interventions': [{'name': 'portable ECG devise', 'type': 'DEVICE', 'armGroupLabels': ['Healthy', 'OSA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '220', 'city': 'New Taipei City', 'country': 'Taiwan', 'facility': 'Far Eastern Memorial Hospital', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'overallOfficials': [{'name': 'Ping-huai Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Far Eastern Memeorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Far Eastern Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief', 'investigatorFullName': 'Ping-Huai Wang', 'investigatorAffiliation': 'Far Eastern Memorial Hospital'}}}}