Sleep Disturbances as a Risk Factor in Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

— CRIC  

Official title:

Sleep Disturbance as a Non-Traditional Risk Factor in CKD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00817427
• Other study ID #: #14075A
• Secondary ID: 5RO1DK71696-4
• Status: Completed
• Phase: N/A
• First received: January 5, 2009
• Last updated: September 4, 2013
• Start date: October 2008
• Est. completion date: July 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: Interventional

Clinical Trial Summary

This study is designed to determine if either short night time sleep or poor night time sleep could be a risk factor for increasing the rate at which kidney function deteriorates in persons with mild to moderate kidney disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 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:

• 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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

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

Intervention

Other:
• Controls Short sleep
Healthy control subject's bedtime will be decreased by 2 hours/night with acoustic sleep disruption
• CKD- sleep extension
Sleep will be increased by 2 hours each night for 3 nights

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of chronobiological profiles of renin/aldosterone, sympatho-vagal balance and CV function in CKD subjects to controls at baseline and after extended sleep in CKD subjects and after decreased time and quality of sleep in control subjects.		Immediately after intervention.	No