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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00817427
Recruitment Status : Completed
First Posted : January 6, 2009
Last Update Posted : September 5, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Chronic Kidney Disease Other: Controls Short sleep Other: CKD- sleep extension

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Sleep Disturbance as a Non-Traditional Risk Factor in CKD
Study Start Date : October 2008
Primary Completion Date : June 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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. ]

Eligibility Criteria

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Ages Eligible for Study:   21 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00817427


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

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00817427     History of Changes
Other Study ID Numbers: #14075A
5RO1DK71696-4
First Posted: January 6, 2009    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: September 2013

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

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