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OpenTrials
Completed

NCT Number: NCT00817674

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

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. CKD progression as measured by changes in GFR and cardiovascular risk as measured by CRP over a 5 year period

    Time frame: 5 years

Secondary outcomes

  1. insulin resistance

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Case Western Reserve University
  • University of Illinois at Chicago

Registry information

Official study title

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

Acronym: CRIC

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jan 6, 2009
Registry last updated
Sep 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.