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NCT00817492 Clinical Trial

Sleep Disturbances as a Non-Traditional Risk Factor in Chronic Kidney Disease- University of Illinois

Chronic Kidney Disease Clinical Trial

— CRIC  

Official title:
Sleep Disturbances as a Non-Traditional Risk Factor in Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00817492
Other study ID # #14747A
Secondary ID 5RO1DK071696
Status Completed
Phase N/A
First received January 5, 2009
Last updated September 4, 2013
Start date July 2006
Est. completion date June 2011

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

This study will help determine the relationship between impaired sleep and chronic kidney disease, specifically to determine if sleep disturbances are a risk factor for worsening kidney function.

Recruitment information / eligibility
Status Completed
Enrollment 89
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 74 Years
Eligibility Inclusion Criteria:

- CKD subjects will be participants in a larger study, CRIC, at the University of Illinois, Chicago

- 30 Healthy controls age and gender matched to 30 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

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

Sponsors (2)
Lead Sponsor Collaborator
University of Chicago University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sleep Quality Sleep Quality was determined after PSG on all subjects were completed No
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