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Sleep Disturbances as a Risk Factor in Chronic Kidney Disease (CRIC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University of Chicago.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00817427
First received: January 5, 2009
Last updated: January 27, 2011
Last verified: January 2011
History of Changes
  Purpose

This study is designed to determine if either short night time sleep or poor night time sleep could be a risk factor for increasing the rate at which kidney function deteriorates in persons with mild to moderate kidney disease.


Condition Intervention
Chronic Kidney Disease
 Other: Controls Short sleep
Other: CKD- sleep extension

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Sleep Disturbance as a Non-Traditional Risk Factor in CKD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Comparison of chronobiological profiles of renin/aldosterone, sympatho-vagal balance and CV function in CKD subjects to controls at baseline and after extended sleep in CKD subjects and after decreased time and quality of sleep in control subjects. [ Time Frame: Immediately after intervention. ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2008
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Baseline
CKD subjects and healthy, matched controls will have measures of cardiovascular function (BP, HR) measure of hormonal fluid balance (renin/aldosterone) measure and measures of glucose metabolism (response to glucose load and over 24 hr profile) with 3 days of habitual sleep time
Experimental: CKD- Sleep extension
Measures as in baseline but with bed time increased by 2 hours
 Other: CKD- sleep extension
SLeep will be increased by 2 hours each night for 3 nights
Other Name: Sleep intervention
Experimental: Controls short sleep
Measures as in baseline but with sleep disruption
 Other: Controls Short sleep
Healthy control subject's bedtime will be decreased by 2 hours/night with acoustic sleep disruption
Other Name: Sleep intervention

  Eligibility

Ages Eligible for Study:   21 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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: NCT00817427

Contacts
Contact: Annette Miller, RN, MSN 773-834-8871 amiller@medicine.bsd.uchicago.edu

Locations
United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Principal Investigator: Eve Van Cauter, PhD            
Sponsors and Collaborators
University of Chicago
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: NCT00817427     History of Changes
Other Study ID Numbers: #14075A, 5RO1DK71696-4
Study First Received: January 5, 2009
Last Updated: January 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Chronic Kidney Disease
Poor sleep
CKD
Kidney Failure

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