Sleep Disturbances as a Non-Traditional Risk Factor in CKD-Actigraphy - Full Text View

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

This study is currently recruiting participants.

Verified by University of Chicago, January 2009

Sponsors and Collaborators:	University of Chicago University of Illinois Case Western Reserve University
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00817674

Purpose

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.

Condition
Chronic Kidney Disease Sleep Loss

MedlinePlus related topics: Sleep Disorders

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Sleep Disturbances as a Non-Traditional Risk Factor in CKD-Wrist Actigraphy

Further study details as provided by University of Chicago:

Primary Outcome Measures:

CKD progression as measured by changes in GFR and cardiovascular risk as measured by CRP over a 5 year period [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

insulin resistance [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	800
Study Start Date:	November 2008

Groups/Cohorts
1 CKD subjects
2 Healthy Controls

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

CKD subjects; healthy volunteers

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: NCT00817674

Contacts

Contact: Kristen Knutson, PhD

773-834-1973

kknutson@health.uchicago.edu

Locations

United States, Illinois
The University of Chicago	Recruiting
Chicago, Illinois, United States, 60637
Contact: Kristen Knutson, PhD 773-834-1973 kknutson@health.uchicago.edu
Principal Investigator: Eve Van Cauter, PhD

Sponsors and Collaborators

University of Chicago

University of Illinois

Case Western Reserve University

Investigators

Principal Investigator:

Eve Van Cauter, PhD

University of Chicago

More Information

Responsible Party:	The University of Chicago ( Eve Van Cauter, PhD, Professor )
Study ID Numbers:	#14081A, 5RO1DK71696
Study First Received:	January 5, 2009
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00817674
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Chicago:

CKD
Kidney Disease
poor sleep
CKD progression

Study placed in the following topic categories:

Signs and Symptoms
Renal Insufficiency
Urologic Diseases
Mental Disorders
Renal Insufficiency, Chronic
Disease Progression

Kidney Failure, Chronic
Neurologic Manifestations
Dyssomnias
Sleep Disorders
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 13, 2009