Text Size

Sleep Disturbances as a Non-traditional Risk Factor in CKD-Actigraphy (CRIC)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
University of Illinois
Case Western Reserve University
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00817674
First received: January 5, 2009
Last updated: October 8, 2009
Last verified: October 2009
History of Changes
  Purpose

To test if usual at home night time sleep duration as measured with activity monitors and questionnaires will predict changes in kidney function as measured by kidney filtration rate and of cardiovascular function as measured by C-reactive protein in the blood. The study will explore the role of decreased sleep time or decreased sleep quality as a non-traditional risk factor for the progression of CKD and for the development of cardiovascular disease in CKD.


Condition
Chronic Kidney Disease
Sleep Loss

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Sleep Disturbances as a Non-traditional Risk Factor in CKD-Wrist Actigraphy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • CKD progression as measured by changes in GFR and cardiovascular risk as measured by CRP over a 5 year period [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • insulin resistance [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: November 2007
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
CKD subjects
2
Healthy Controls

  Eligibility

Ages Eligible for Study:   21 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

CKD subjects; healthy volunteers

Criteria

Inclusion Criteria:

  • Mild to Moderate CKD
  • Healthy controls age and gender matched to 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00817674

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
University of Illinois
Case Western Reserve University
Investigators
Principal Investigator: Eve Van Cauter, PhD University of Chicago
  More Information

No publications provided

Responsible Party: Eve Van Cauter, PhD, Professor, The University of Chicago
ClinicalTrials.gov Identifier: NCT00817674     History of Changes
Other Study ID Numbers: #14081A, 5RO1DK71696
Study First Received: January 5, 2009
Last Updated: October 8, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
CKD
Kidney Disease
poor sleep
CKD progression

Additional relevant MeSH terms:
Kidney Diseases
Sleep Disorders
Dyssomnias
Parasomnias
Renal Insufficiency, Chronic
Kidney Failure, Chronic
 Urologic Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Renal Insufficiency

ClinicalTrials.gov processed this record on May 23, 2013