Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-01-02 @ 2:01 PM
Study NCT ID:
NCT00597103
Status:
COMPLETED
Last Update Posted:
2019-04-18
First Post:
2008-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Dialysis Therapies on Cognitive Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D012148', 'term': 'Restless Legs Syndrome'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2011-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-16', 'studyFirstSubmitDate': '2008-01-08', 'studyFirstSubmitQcDate': '2008-01-08', 'lastUpdatePostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distribution of cognitive function impairment in ESRD patients undergoing more frequent hemodialysis', 'timeFrame': 'baseline, 4 months and 12 months'}], 'secondaryOutcomes': [{'measure': 'Longitudinal analysis of cognitive function over time to test the hypothesis that more frequent hemodialysis contributes to delay in cognitive function impairment', 'timeFrame': 'baseline, 4 months and 12 months'}, {'measure': 'To test the hypothesis that nightly or daily hemodialysis treatment can ultimately be proven to be cost effective options by preserving cognitive function.', 'timeFrame': '12 months'}, {'measure': 'Influence of cognitive function on survival.', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hemodialysis', 'Frequent Hemodialysis', 'Sleep Apnea', 'Restless Leg Syndrome', 'Cognitive Function'], 'conditions': ['End Stage Renal Disease', 'Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effects of more frequent dialysis on cognitive function including the assessment of sleep apnea and restless legs. Our hypothesis is that more frequent dialysis improves cognitive function and may have important implications on clinical care of ESRD patients and help to emphasize the need for treatments that will allow patients to live "with dialysis" rather than live "for dialysis".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with Chronic Kidney Disease (CKD) who require renal replacement therapy and who are currently receiving dialysis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of ESRD\n* Age 18 years or greater\n* Ability to understand and a willingness to sign an informed consent statement and a Health Insurance Portability and Accountability Act of 1996 (HIPPA) authorization statement.\n* Expected survival of at least one year.\n\nExclusion Criteria:\n\n* Documented non-compliance, defined as missing more than 10% of prescribed treatments during the month prior to the start of the study.'}, 'identificationModule': {'nctId': 'NCT00597103', 'briefTitle': 'Comparison of Dialysis Therapies on Cognitive Function', 'organization': {'class': 'OTHER', 'fullName': 'Satellite Healthcare'}, 'officialTitle': 'Comparison of Dialysis Therapies on Cognitive Function', 'orgStudyIdInfo': {'id': 'SR016CF'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Prevalent patients who have been receiving more frequent dialysis.', 'interventionNames': ['Other: Cognitive Function Testing-10 Tests', 'Other: Sleep Assessment Testing', 'Other: Periodic Leg Movement Syndrome Assessment']}, {'label': '2', 'description': 'Incident patients new to more frequent dialysis', 'interventionNames': ['Other: Cognitive Function Testing-10 Tests', 'Other: Sleep Assessment Testing', 'Other: Periodic Leg Movement Syndrome Assessment']}, {'label': '3', 'description': 'Patients who switch from one more frequent hemodialysis treatment regimen to another more frequent dialysis regimen.', 'interventionNames': ['Other: Cognitive Function Testing-10 Tests', 'Other: Sleep Assessment Testing', 'Other: Periodic Leg Movement Syndrome Assessment']}], 'interventions': [{'name': 'Cognitive Function Testing-10 Tests', 'type': 'OTHER', 'description': 'Trailmaking A, Trailmaking B, Rey Auditory Verbal Learning, Letter Number Sequencing, Digit Symbol Substitution, Grooved Pegboard, Controlled Oral Word Association, Beck Depression Index, Feeling Thermometer, Modified Mini-Mental Status', 'armGroupLabels': ['1', '2', '3']}, {'name': 'Sleep Assessment Testing', 'type': 'OTHER', 'description': 'Sleep Assessment will be performed using an "Actiwatch" with subjects wearing the watch for 72 hours continuously', 'armGroupLabels': ['1', '2', '3']}, {'name': 'Periodic Leg Movement Syndrome Assessment', 'type': 'OTHER', 'description': 'Subjects will wear and "Actiwatch" on both legs for three consecutive nights.', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94041', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Healthcare, Inc', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '94041', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'WellBound, Inc.', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}], 'overallOfficials': [{'name': 'Brigitte Schiller-Moran, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Satellite Healthcare, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Satellite Healthcare', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}