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

Study Overview
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Brief Summary
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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 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.

Detailed Description
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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.

Official Title
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The Effects of Hemodialysis on the Sleep/Wake Cycle

Conditions
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End-stage Renal Disease

Intervention / Treatment
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* Procedure: Cool Dialysate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>The control group received standard dialysis at a temperature of 37 degrees Celcius | |
| Experimental: Experimental group<br>Subjects in the experimental group received cool dialysate during treatment | Procedure: Cool Dialysate<br>* Decreased temperature of the dialysis bath<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total sleep time | amount of time slept per night | 9months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | Quality of life as defined by the Ferrans and Powers QOL Inventory | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep, Renal failure, Dialysis