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Sleep Disturbances as a Non-Traditional Risk Factor in Chronic Kidney Disease- University of Illinois (CRIC)

This study has been completed.
Sponsor:
Collaborator:
University of Illinois at Chicago
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00817492
First received: January 5, 2009
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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.


Condition
Chronic Kidney Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Sleep Disturbances as a Non-Traditional Risk Factor in Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Sleep Quality [ Time Frame: Sleep Quality was determined after PSG on all subjects were completed ] [ Designated as safety issue: No ]

Enrollment: 89
Study Start Date: July 2006
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Subjects with mild to moderate kidney disease
2
Healthy Control Subjects

  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

Renal Clinic patients at The University of Illinois at Chicago Hospital

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817492

Locations
United States, Illinois
The University of Illinois at Chicago
Chicago, Illinois, United States
Sponsors and Collaborators
University of Chicago
University of Illinois at Chicago
Investigators
Principal Investigator: Eve Van Cauter, PhD University of Chicago
Principal Investigator: James Lash, MD University of Illinois at Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00817492     History of Changes
Other Study ID Numbers: #14747A, 5RO1DK071696
Study First Received: January 5, 2009
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Sleep
CKD
kidney
PSG
polysomnography
Decreased sleep time
Decreased sleep quality

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

ClinicalTrials.gov processed this record on November 25, 2014