Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2026-06-14 @ 3:57 AM
Study NCT ID:
NCT03009357
Status:
COMPLETED
Last Update Posted:
2018-04-18
First Post:
2016-12-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Application of Pulse Rate-monitoring Activity Trackers in Thyrotoxicosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013971', 'term': 'Thyrotoxicosis'}, {'id': 'D006111', 'term': 'Graves Disease'}, {'id': 'D013966', 'term': 'Thyroiditis'}], 'ancestors': [{'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-16', 'studyFirstSubmitDate': '2016-12-29', 'studyFirstSubmitQcDate': '2016-12-30', 'lastUpdatePostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between parameters of pulse rate, activity, and sleep from wearable activity trackers and the thyrotoxic status', 'timeFrame': 'continuous monitoring through the study period (average 3 months)'}], 'secondaryOutcomes': [{'measure': 'Association between user-generated dietary parameters on mobile applications and the thyrotoxic status', 'timeFrame': 'continuous monitoring through the study period (average 3 months)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['wearable activity tracker', 'thyrotoxicosis'], 'conditions': ['Thyrotoxicosis', 'Graves Disease', 'Thyroiditis']}, 'referencesModule': {'references': [{'pmid': '30006328', 'type': 'DERIVED', 'citation': 'Lee JE, Lee DH, Oh TJ, Kim KM, Choi SH, Lim S, Park YJ, Park DJ, Jang HC, Moon JH. Clinical Feasibility of Monitoring Resting Heart Rate Using a Wearable Activity Tracker in Patients With Thyrotoxicosis: Prospective Longitudinal Observational Study. JMIR Mhealth Uhealth. 2018 Jul 13;6(7):e159. doi: 10.2196/mhealth.9884.'}, {'pmid': '29467121', 'type': 'DERIVED', 'citation': 'Lee JE, Lee DH, Oh TJ, Kim KM, Choi SH, Lim S, Park YJ, Park DJ, Jang HC, Moon JH. Clinical Feasibility of Continuously Monitored Data for Heart Rate, Physical Activity, and Sleeping by Wearable Activity Trackers in Patients with Thyrotoxicosis: Protocol for a Prospective Longitudinal Observational Study. JMIR Res Protoc. 2018 Feb 21;7(2):e49. doi: 10.2196/resprot.8119.'}]}, 'descriptionModule': {'briefSummary': 'The study is a single-center prospective cohort study of clinical application of continuously monitored data by wearable activity trackers in the patients with thyrotoxicosis. The purpose of the study is to evaluate the association between parameters of pulse rate, activity, and sleep from wearable activity trackers and the thyrotoxic status along with the treatment.', 'detailedDescription': 'Activity trackers to be used: Fitbit Charge HR (TM)\n\nData which ware provided by Fitbit app (TM) will be analyzed in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults (20 to 60 years) undergoing newly developed or recurrent thyrotoxicosis who can use wearable activity trackers and smartphone applications', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients undergoing newly developed or recurrent thyrotoxicosis who are treated and followed-up in Seoul National University Bundang Hospital\n* Patients who can use wearable activity trackers and smartphone applications\n* In case of Graves' disease, patients who will treated by anti-thyroid drugs\n\nExclusion Criteria:\n\n* Patients who have thyrotoxic periodic paralysis\n* In case of Graves' disease, patients who will treated by radioactive iodine therapy or thyroidectomy\n* Patients who have thyrotoxicosis due to toxic nodular disease"}, 'identificationModule': {'nctId': 'NCT03009357', 'acronym': 'AT-thyro', 'briefTitle': 'Clinical Application of Pulse Rate-monitoring Activity Trackers in Thyrotoxicosis', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Clinical Application of Continuous Monitoring Data for the Pulse Rate, Exercise, and Calorie Intake by Wearable Activity Trackers in the Patients With Thyrotoxicosis', 'orgStudyIdInfo': {'id': 'B-1609/363-004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'thyrotoxicosis', 'description': 'patients with newly detected or recurrent thyrotoxicosis'}, {'label': 'control', 'description': 'euthyroid, healthy adults'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Jae Hoon Moon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Jae Hoon Moon', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}