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

NCT00218790 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2014-02-12

No results posted yet for this study

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.

Conditions

  • End-stage Renal Disease

Interventions

PROCEDURE

Cool Dialysate

Decreased temperature of the dialysis bath

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Kathy P. Parker, PhD,RN,FAAN · Emory University, Nell Hodgson Woodruff School of Nursing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00218790 on ClinicalTrials.gov