The Effects of Cool Dialysate on the Sleep/Wake Cycle in Patients on Chronic Hemodialysis - "The Sleep Cool Study"

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 quantity and quality. Therefore, a major component of this study is to test
a novel application for a safe, non-pharmacologic, cost-effective intervention that is
alreay in use in clinical practice - using cool dialysate during hemodialysis to help
stabilize the sleep/wake cycle of chronic hemodialysis patients. We will also evaluate its
effects on selected sleep-related physiologic, psychological, behavioral, and general health
outcomes.

To test the efficacy of this intervention, a randomized, single-blinded, pretest-posttest,
control group design is being used. The major independent variable is dialysate
temperature. The major dependent variables are measures of sleep, body temperature,
rest/activity patterns, and general health outcomes.

Inclusion Criteria:

- All races, cause of renal failure is diabetes, hypertension, glomerulonephritis, or
polycystic kidney disease; ability to read and write in English; clinically stable.

Exclusion Criteria:

- Current use of sleeping medication; history of alcoholism or drug abuse; brain
disease; severe hypertension; severe heart disease; low functional level