Sleep Disturbances as a Risk Factor in Chronic Kidney Disease
CRIC
Sleep Disturbance as a Non-Traditional Risk Factor in CKD
3 other identifiers
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 5, 2009
CompletedFirst Posted
Study publicly available on registry
January 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedSeptember 5, 2013
September 1, 2013
2.7 years
January 5, 2009
September 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (3)
Baseline
NO INTERVENTIONCKD subjects and healthy, matched controls will have measures of cardiovascular function (BP, HR) measure of hormonal fluid balance (renin/aldosterone) measure and measures of glucose metabolism (response to glucose load and over 24 hr profile) with 3 days of habitual sleep time
CKD- Sleep extension
EXPERIMENTALMeasures as in baseline but with bed time increased by 2 hours
Controls short sleep
EXPERIMENTALMeasures as in baseline but with sleep disruption
Interventions
Healthy control subject's bedtime will be decreased by 2 hours/night with acoustic sleep disruption
Sleep will be increased by 2 hours each night for 3 nights
Eligibility Criteria
You may qualify if:
- Mild to Moderate CKD
- Healthy controls age and gender matched to CKD subjects
- Regular bedtimes of at least 6h/night, sedentary lifestyle
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Chicago
Chicago, Illinois, 60637, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eve Van Cauter, PhD
University of Chicago
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2009
First Posted
January 6, 2009
Study Start
October 1, 2008
Primary Completion
June 1, 2011
Study Completion
July 1, 2011
Last Updated
September 5, 2013
Record last verified: 2013-09