Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-01-03 @ 11:32 PM
Study NCT ID:
NCT00817492
Status:
COMPLETED
Last Update Posted:
2013-09-05
First Post:
2009-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Disturbances as a Non-Traditional Risk Factor in Chronic Kidney Disease- University of Illinois
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-04', 'studyFirstSubmitDate': '2009-01-05', 'studyFirstSubmitQcDate': '2009-01-05', 'lastUpdatePostDateStruct': {'date': '2013-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep Quality', 'timeFrame': 'Sleep Quality was determined after PSG on all subjects were completed'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sleep', 'CKD', 'kidney', 'PSG', 'polysomnography', 'Decreased sleep time', 'Decreased sleep quality'], 'conditions': ['Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'This study will help determine the relationship between impaired sleep and chronic kidney disease, specifically to determine if sleep disturbances are a risk factor for worsening kidney function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Renal Clinic patients at The University of Illinois at Chicago Hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CKD subjects will be participants in a larger study, CRIC, at the University of Illinois, Chicago\n* 30 Healthy controls age and gender matched to 30 CKD subjects, regular bedtimes of at least 6h/night, sedentary lifestyle\n\nExclusion Criteria:\n\n* Diabetes\n* Current or previous dialysis for more than 1 month\n* Uncontrolled hypertension\n* Heart failure\n* Liver disease\n* HIV\n* Hemoglobin \\< 10.5 g/dl\n* Treatment with EProcrit, Epogen, or Aranesp\n* Bone or organ transplant,\n* Use of immunosuppressive drugs within past 6 months\n* Current oral contraceptive use\n* Current pregnancy\n* Chemotherapy for malignancy within past 2 years'}, 'identificationModule': {'nctId': 'NCT00817492', 'acronym': 'CRIC', 'briefTitle': 'Sleep Disturbances as a Non-Traditional Risk Factor in Chronic Kidney Disease- University of Illinois', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Sleep Disturbances as a Non-Traditional Risk Factor in Chronic Kidney Disease', 'orgStudyIdInfo': {'id': '#14747A'}, 'secondaryIdInfos': [{'id': '5R01DK071696', 'link': 'https://reporter.nih.gov/quickSearch/5R01DK071696', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Subjects with mild to moderate kidney disease'}, {'label': '2', 'description': 'Healthy Control Subjects'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Eve Van Cauter, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}, {'name': 'James Lash, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Illinois at Chicago', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}