Status:
COMPLETED
The Effects of Cool Dialysate on the Sleep/Wake Cycle in Patients on Chronic Hemodialysis - "The Sleep Cool Study"
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
End-stage Renal Disease
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
A major component of this study is to test a novel application for a safe, non-pharmacologic, cost-effective intervention that is already in use in clinical practice - using cool dialysate during hemo...
Detailed Description
Preliminary results demonstrate that, after one treatment, using cool dialysate instead of warm dialysate markedly normalized the rhythm of body temperature and improved indices on nocturnal sleep qua...
Eligibility Criteria
Inclusion
- All races, cause of renal failure is diabetes, hypertension, glomerulonephritis, or polycystic kidney disease; ability to read and write in English; clinically stable.
Exclusion
- Current use of sleeping medication; history of alcoholism or drug abuse; brain disease; severe hypertension; severe heart disease; low functional level
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00218790
Start Date
April 1 2003
End Date
April 1 2008
Last Update
February 12 2014
Active Locations (2)
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1
Emory affiliated hemodialysis units
Atlanta, Georgia, United States, 30080
2
Emory University affiliated hemodialysis units
Atlanta, Georgia, United States, 30322