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

September 4, 2013 updated by: University of Chicago

Sleep Disturbance as a Non-Traditional Risk Factor in CKD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago

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

No

Genders Eligible for Study

All

Description

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

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

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Sleep intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Immediately after intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Eve Van Cauter, PhD, University of 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

October 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

July 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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #14075A
  • 5RO1DK71696-4

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.

Clinical Trials on Chronic Kidney Disease

Clinical Trials on CKD- sleep extension

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe