- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00817492
Sleep Disturbances as a Non-Traditional Risk Factor in Chronic Kidney Disease- University of Illinois (CRIC)
September 4, 2013 updated by: University of Chicago
Sleep Disturbances as a Non-Traditional Risk Factor in Chronic Kidney Disease
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
89
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States
- The University of Illinois at Chicago
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Renal Clinic patients at The University of Illinois at Chicago Hospital
Description
Inclusion Criteria:
- CKD subjects will be participants in a larger study, CRIC, at the University of Illinois, Chicago
- 30 Healthy controls age and gender matched to 30 CKD subjects, regular bedtimes of at least 6h/night, sedentary lifestyle
Exclusion Criteria:
- Diabetes
- Current or previous dialysis for more than 1 month
- Uncontrolled hypertension
- Heart failure
- Liver disease
- HIV
- Hemoglobin < 10.5 g/dl
- Treatment with EProcrit, Epogen, or Aranesp
- Bone or organ transplant,
- Use of immunosuppressive drugs within past 6 months
- Current oral contraceptive use
- Current pregnancy
- Chemotherapy for malignancy within past 2 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
Subjects with mild to moderate kidney disease
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2
Healthy Control Subjects
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sleep Quality
Time Frame: Sleep Quality was determined after PSG on all subjects were completed
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Sleep Quality was determined after PSG on all subjects were completed
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Eve Van Cauter, PhD, University of Chicago
- Principal Investigator: James Lash, MD, University of Illinois at Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
January 5, 2009
First Submitted That Met QC Criteria
January 5, 2009
First Posted (Estimate)
January 6, 2009
Study Record Updates
Last Update Posted (Estimate)
September 5, 2013
Last Update Submitted That Met QC Criteria
September 4, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- #14747A
- 5R01DK071696 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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