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

Chronic Kidney Disease Clinical Trial

— CRIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00817674
• Other study ID #: #14081A
• Secondary ID: 5RO1DK71696
• Status: Completed
• Phase: N/A
• First received: January 5, 2009
• Last updated: September 4, 2013
• Start date: November 2007
• Est. completion date: October 2010

Study information

• Verified date: September 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 74 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Dyssomnias
• Kidney Diseases
• Parasomnias
• Renal Insufficiency, Chronic
• Sleep Disorders
• Sleep Loss

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Chicago	Case Western Reserve University, University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CKD progression as measured by changes in GFR and cardiovascular risk as measured by CRP over a 5 year period		5 years	No
Secondary	insulin resistance		5 years	No