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

September 4, 2013 updated by: University of Chicago

Sleep Disturbances as a Non-traditional Risk Factor in CKD-Wrist Actigraphy

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

353

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

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

CKD subjects; healthy volunteers

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

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
2 Healthy Controls
1 CKD subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
CKD progression as measured by changes in GFR and cardiovascular risk as measured by CRP over a 5 year period Time Frame: 5 years	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
insulin resistance Time Frame: 5 years	5 years

Collaborators and Investigators

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

Sponsor

University of Chicago

Collaborators

University of Illinois at Chicago

Case Western Reserve University

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

November 1, 2007

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

January 5, 2009

First Submitted That Met QC Criteria