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

Not Applicable

Completed

• Conditions: End-stage Renal Disease
• Interventions: Procedure: Cool Dialysate

• Registration Number: NCT00218790
• Lead Sponsor: Emory University

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 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

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.

Study Timeline

• Study Start: 2003-04
• Status Verified: 2005-09
• Study First Submitted: 2005-09-16
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-22
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Last Update Submitted: 2014-02-10
• Last Update Posted: 2014-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Cool Dialysate	Subjects in the experimental group received cool dialysate during treatment

Primary Outcome Measures

Name	Time	Method
total sleep time	9months	amount of time slept per night

Secondary Outcome Measures

Name	Time	Method
quality of life	9 months	Quality of life as defined by the Ferrans and Powers QOL Inventory

Trial Locations

Locations (2)

Emory University affiliated hemodialysis units; 🇺🇸 Atlanta, Georgia, United States

Emory affiliated hemodialysis units; 🇺🇸 Atlanta, Georgia, United States