Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT04806269
Status:
UNKNOWN
Last Update Posted:
2023-04-13
First Post:
2021-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biosignals by Wearables in Thyroid Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013971', 'term': 'Thyrotoxicosis'}, {'id': 'D007037', 'term': 'Hypothyroidism'}], 'ancestors': [{'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-11', 'studyFirstSubmitDate': '2021-01-26', 'studyFirstSubmitQcDate': '2021-03-17', 'lastUpdatePostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'free T4', 'timeFrame': 'visit 2: 1-2 weeks after enrollement (visit 1)', 'description': 'serum concentration of free T4'}, {'measure': 'free T4', 'timeFrame': 'visit 3 : 4 weeks after visit 2', 'description': 'serum concentration of free T4'}, {'measure': 'free T4', 'timeFrame': 'visit 4 : 4 weeks after visit 3', 'description': 'serum concentration of free T4'}, {'measure': 'TSH', 'timeFrame': 'visit 2: 1-2 weeks after enrollement (visit 1)', 'description': 'serum concentration of TSH'}, {'measure': 'TSH', 'timeFrame': 'visit 3 : 4 weeks after visit 2', 'description': 'serum concentration of TSH'}, {'measure': 'TSH', 'timeFrame': 'visit 4 : 4 weeks after visit 3', 'description': 'serum concentration of TSH'}, {'measure': 'heart rate', 'timeFrame': 'throughout the study period (average 3 months)', 'description': 'continuously monitored heart rate by wearable device'}, {'measure': 'Activity_steps (count/min)', 'timeFrame': 'throughout the study period (average 3 months)', 'description': 'continuously monitored steps per minute by wearable device'}, {'measure': 'Sleep_sleep start time (yyyy:mm:dd:hh:mm:ss)', 'timeFrame': 'throughout the study period (average 3 months)', 'description': 'sleep start time extracted from continuously monitored sleep data by wearable device (e.q. 2021:03:15:23:00:00)'}, {'measure': 'Sleep_sleep end time (yyyy:mm:dd:hh:mm:ss)', 'timeFrame': 'throughout the study period (average 3 months)', 'description': 'sleep end time extracted from continuously monitored sleep data by wearable device (e.q. 2021:03:16:06:00:00)'}, {'measure': 'Hyperthyroid symptom scale', 'timeFrame': 'visit 2: 1-2 weeks after enrollement (visit 1)', 'description': 'HSS gives scores from 0 to 40, where higher scores indicate more severe disease. It consists of a 10-item scale that rates nervousness, diaphoresis, heat intolerance, motor activity, tremor, weakness, hyperdynamic precordium, diarrhea, weight loss/appetite, and overall function.'}, {'measure': "Zulewski's clinical score", 'timeFrame': 'visit 2: 1-2 weeks after enrollement (visit 1)', 'description': 'Clinical scoring system for assessing hypothyroid symptoms and signs (0-12, higher scores indicate more severe)'}, {'measure': 'Hyperthyroid symptom scale', 'timeFrame': 'visit 3 : 4 weeks after visit 2', 'description': 'HSS gives scores from 0 to 40, where higher scores indicate more severe disease. It consists of a 10-item scale that rates nervousness, diaphoresis, heat intolerance, motor activity, tremor, weakness, hyperdynamic precordium, diarrhea, weight loss/appetite, and overall function.'}, {'measure': "Zulewski's clinical score", 'timeFrame': 'visit 3 : 4 weeks after visit 2', 'description': 'Clinical scoring system for assessing hypothyroid symptoms and signs (0-12, higher scores indicate more severe)'}, {'measure': 'Hyperthyroid symptom scale', 'timeFrame': 'visit 4 : 4 weeks after visit 3', 'description': 'HSS gives scores from 0 to 40, where higher scores indicate more severe disease. It consists of a 10-item scale that rates nervousness, diaphoresis, heat intolerance, motor activity, tremor, weakness, hyperdynamic precordium, diarrhea, weight loss/appetite, and overall function.'}, {'measure': "Zulewski's clinical score", 'timeFrame': 'visit 4 : 4 weeks after visit 3', 'description': 'Clinical scoring system for assessing hypothyroid symptoms and signs (0-12, higher scores indicate more severe)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Wearable device', 'Biosignals', 'Thyrotoxicosis', 'Hypothyroidism', 'Mobile app'], 'conditions': ['Thyrotoxicosis', 'Hypothyroidism']}, 'descriptionModule': {'briefSummary': 'This study is a single center observational study to investigate the association between biosignals from wearables and thyroid dysfunction.', 'detailedDescription': 'An algorithm to predict thyroid dysfunction using heart rate and activity data from wearables was generated based on our previous clinical studies. This study was conducted to collect more data to advance the algorithm.\n\nPatients with thyroid dysfunction including hypothyroidism and thyrotoxicosis were eligible for this study. During the study period, each subject wears a smart band (Fitbit Inspire 2 TM) and gets 3 times of thyroid function tests with 1-month interval. Study participants will use a mobile app (Glandy TM) to collect the symptom scores.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Korean adults (age 18-60) who newly diagnosed as thyroid dysfunction (thyrotoxicosis or hypothyroidism) or undergoing treatment', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who were newly diagnosed as thyroid dysfunction (thyrotoxicosis or hypothyroidism) or undergoing treatment\n* Subjects who are able to use wearable devices, smart phones, and mobile apps\n\nExclusion Criteria:\n\n* Subjects with restrictions on normal activities due to diseases other than thyroid dysfunction\n* Subjects who are taking medications affecting heart rate\n* Subjects with diseases affecting heart rate (i.e. arrhythmia)'}, 'identificationModule': {'nctId': 'NCT04806269', 'briefTitle': 'Biosignals by Wearables in Thyroid Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Clinical Application of Continuous Monitoring Data for the Pulse Rate, Exercise, and Symptom Survey by Wearable Device in the Patients With Thyroid Dysfunction', 'orgStudyIdInfo': {'id': 'B-2012-654-303'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Thyroid dysfunction group', 'description': 'Subjects with thyroid dysfunction including thyrotoxicosis and hypothyroidism Subjects who were newly diagnosed or undergoing treatment for thyroid dysfunction can be included in the study.\n\nSubjects should use a wearable device (Fitbit Inspire 2 TM) and a mobile app (Glandy TM) during the study period.', 'interventionNames': ['Device: Fitbit and Glandy']}, {'label': 'Control group', 'description': 'Subjects without thyroid dysfunction including thyrotoxicosis and hypothyroidism.\n\nSubjects should use a wearable device (Fitbit Inspire 2 TM) and a mobile app (Glandy TM) during the study period.', 'interventionNames': ['Device: Fitbit and Glandy']}], 'interventions': [{'name': 'Fitbit and Glandy', 'type': 'DEVICE', 'description': "Data collection from wearable devices (Fitbit Inspire 2 TM) and a mobile app (Glandy TM) Fitbit collects user's heart rate, activity, and sleep data. Glandy collects user's subjective symptom scores.", 'armGroupLabels': ['Control group', 'Thyroid dysfunction group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jae Hoon Moon, MD', 'role': 'CONTACT', 'email': 'jaemoon76@gmail.com', 'phone': '+82-31-787-7068'}, {'name': 'Chang Ho Ahn, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'centralContacts': [{'name': 'Jae Hoon Moon, MD', 'role': 'CONTACT', 'email': 'jaemoon76@gmail.com', 'phone': '+82-31-787-7068'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'SeoulNUBH', 'investigatorFullName': 'Jae Hoon Moon', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}