Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT04207502
Status:
UNKNOWN
Last Update Posted:
2019-12-26
First Post:
2019-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Integrating Systematic Data of Geriatric Medicine to Explore the Solution for Health Aging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood, urine, and stool'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-24', 'studyFirstSubmitDate': '2019-11-26', 'studyFirstSubmitQcDate': '2019-12-19', 'lastUpdatePostDateStruct': {'date': '2019-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The brain volume of local Taiwanese aged over 60 years old', 'timeFrame': 'one hour', 'description': 'Measure the volume of cerebrum, cerebellum, and skin of skull (unit in mm3) by magnetic resonance imaging (MRI)'}, {'measure': 'The monitoring of sleep-related events of local Taiwanese aged over 60 years old', 'timeFrame': 'one night', 'description': 'Measure the sleep stages (unit in minute), apnea-hypopnea index (unit in counts/hour), and respiratory events by polysomnography'}], 'secondaryOutcomes': [{'measure': 'The actigraphy of local Taiwanese aged over 60 years old', 'timeFrame': 'two weeks', 'description': 'Measure the circadian rhythm (unit in minute) by Actiwatch'}, {'measure': 'The neurocognitive questionnaire of local Taiwanese aged over 60 years old', 'timeFrame': 'one day', 'description': 'Measure the neurocognitive condition and sleep quality as assessed by GDS-15, UCLA-LS, HAM-A, HAM-D, AES, TSII, CTQ, AD8, MMSE, ECog, CERAD-NAB, PSQI, ESS, SOS, and STOP-Bang'}, {'measure': 'The gut microbiota of local Taiwanese aged over 60 years old', 'timeFrame': 'one day', 'description': 'Assess the gut bacterial diversity and profile by stool analysis'}, {'measure': 'The metabolism of local Taiwanese aged over 60 years old', 'timeFrame': 'one day', 'description': 'Measure the metabolites as biomarkers by urine and blood analysis'}, {'measure': 'The polysomnographic recording for elderly with obstructive sleep apnea (OSA)', 'timeFrame': 'three months', 'description': 'Subjects with OSA will undergo continuous positive airway pressure (CPAP) and evaluate the improvement rate (unit in percent) by polysomnography and sleepiness questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dementia', 'depression', 'brain structure', 'system biology'], 'conditions': ['Sleep Disturbance', 'Cognitive Change', 'Aging']}, 'referencesModule': {'references': [{'pmid': '41258815', 'type': 'DERIVED', 'citation': 'Liu GH, Huang YH, Yuan TC, Chen YP, Hsu JL, Lee SH, Lin CM, Toh CH, Fang JT, Lin SW, Chuang LP, Chen NH. Associations of Wearable-Measured Sleep and Physical Activity With Memory Performance in Older Adults: Cross-Sectional Study With Actigraphy and MRI. JMIR Aging. 2025 Dec 9;8:e80584. doi: 10.2196/80584.'}]}, 'descriptionModule': {'briefSummary': 'This project aims to build up the comprehensive database of geriatric medicine for local Taiwanese.', 'detailedDescription': 'This project is the pilot for the basis of establishing the schema of database and efficient procedures including subject recruitment, specimen collection, management, and measurement of samples obtained from multiple sources. We will focus on deciphering the correlation of sleep quality and the integrity of brain structure by integrating the holistic health data, socio-demographic characteristics, MRI, wearable technique, and laboratory technology including clinical lab, genotyping, metabolomics, gut microbiome, to unravel the clinical feature of which the age will effect on the frequency of sleep disturbance. This project will not only systematically study the aging effect on the sleep quality and brain structure integrity, but pave the way for exploring a variety of aging-related indications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '100 subjects with aged over 60 years old participated in annual health checkup conducted by either Taipei city or Chang Gung Health and Culture Village.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants of annual health checkup conducted by either Taipei city or Chang Gung Health and Culture Village.\n* aged ≧ 60 years old.\n* have medical record in Chang Gung Memorial Hospital.\n* resided in the Taiwan area over 180 days in past one year.\n\nExclusion Criteria:\n\n* Participants with the medical history of severe organ disorders, severe autoimmune disease, or cancer under treatment.\n* Contraindications or previously failure for receiving brain computerized tomography or magnetic resonance imaging scan.\n* Participants who had receive outpatient clinic follow-ups with diseases that may affect the cognitive evaluation or presentation.\n* Depression with ongoing diagnosis and treatment, suicide idea or suicide behavior in the past 6 months.\n* Difficulty in communication or disabilities'}, 'identificationModule': {'nctId': 'NCT04207502', 'briefTitle': 'Integrating Systematic Data of Geriatric Medicine to Explore the Solution for Health Aging', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Integrating Systematic Data of Geriatric Medicine to Explore the Solution for Health Aging', 'orgStudyIdInfo': {'id': 'CORPG3J0371'}, 'secondaryIdInfos': [{'id': '201900702A3', 'type': 'OTHER', 'domain': 'Chang Gung Medical Foundation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '105', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'CHUNG-HAO LIN, M.D.', 'role': 'CONTACT'}], 'facility': 'Taipei Chang Gung Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '333', 'city': 'Taoyuan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'CHIH-MING LIN, M.D.', 'role': 'CONTACT'}], 'facility': 'Chang Gung Health and Culture Village', 'geoPoint': {'lat': 24.99368, 'lon': 121.29696}}], 'centralContacts': [{'name': 'JI-TSENG FANG, M.D.', 'role': 'CONTACT', 'email': 'fangjits@cgmh.org.tw', 'phone': '+886-3-3281200', 'phoneExt': '8181'}], 'overallOfficials': [{'name': 'JI-TSENG FANG, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Chang Gung Memorial Hospital'}, {'name': 'NING-HUNG CHEN, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}, {'name': 'GENG-HAO LIU, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}, {'name': 'JUNG LUNG HSU, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}, {'name': 'SHWU-HUA LEE, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}, {'name': 'CHIH-MING LIN, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}, {'name': 'CHUNG-HAO LIN, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}, {'name': 'CHENG HONG TOH, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}, {'name': 'CHENG-HSUN CHIU, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}, {'name': 'MEI-LING CHENG, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chang Gung University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}