Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-30 @ 4:37 AM
Study NCT ID:
NCT01327560
Status:
UNKNOWN
Last Update Posted:
2011-04-01
First Post:
2011-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Quality and Related Factors in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D012148', 'term': 'Restless Legs Syndrome'}, {'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], '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': 'D020447', 'term': 'Parasomnias'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-03-31', 'studyFirstSubmitDate': '2011-03-30', 'studyFirstSubmitQcDate': '2011-03-31', 'lastUpdatePostDateStruct': {'date': '2011-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-01', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hemodialysis patients', 'sleep quality', 'restless legs syndrome', 'excessive daytime sleepiness', 'sleep apnea syndrome'], 'conditions': ['Haemodialysis-induced Symptom']}, 'descriptionModule': {'briefSummary': 'Sleep quality is an important predictor of healthy status,quality of life and life span. Sleeping problems affect 50%\\~80% in hemodialysis patients. Sleep quality and related factors research in hemodialysis patients has been discussed and studied globally. Previous studies show insomnia, excessive daytime sleepiness(EDS), sleep apnea syndrome(SAS), restless legs syndrome(RLS) are major causes of poor sleep quality . There is few data to show the influential factors related to sleep quality in Taiwanese hemodialysis patients.', 'detailedDescription': 'This study will be a cross-sectional design with purposive sample from 2 different dialysis medical centers in Taipei. Two hundred hemodialysis patients meeting inclusion criteria will be recruited.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hemodialysis Patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hemodialysis patient whose age ≧ 20 years old and conscious clear.\n* ICD9：585.6\n* Every week receives two or three convention hemodialysis treatment above three months.\n* May communication with Mandarin or Taiwanese language.\n* Patient or caregiver is willing to participate study and sign the inform consent.\n\nExclusion Criteria:\n\n* Hospitalized hemodialysis patient in recently one month.\n* Hemodialysis patient had conscious disturbance, blind or dementia.\n* Hemodialysis Patient refuse to interview or fill out questionnaires.'}, 'identificationModule': {'nctId': 'NCT01327560', 'briefTitle': 'Sleep Quality and Related Factors in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University WanFang Hospital'}, 'officialTitle': 'Sleep Quality and Related Factors in Hemodialysis Patients', 'orgStudyIdInfo': {'id': '100003'}}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Medical University - WanFang Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Tso-Hsiao Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Medical University WanFang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University WanFang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Tso-Hsiao Chen', 'oldOrganization': 'Department of Nephrology, WanFang Hospital'}}}}