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

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ClinicalTrials.gov Identifier: NCT00218790
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 12, 2014
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Kathy P. Parker, PhD, RN, FAAN, 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.

Condition or disease Intervention/treatment Phase
End-stage Renal Disease Procedure: Cool Dialysate Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Hemodialysis on the Sleep/Wake Cycle
Study Start Date : April 2003
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control group
The control group received standard dialysis at a temperature of 37 degrees Celcius
Experimental: Experimental group
Subjects in the experimental group received cool dialysate during treatment
Procedure: Cool Dialysate
Decreased temperature of the dialysis bath



Primary Outcome Measures :
  1. total sleep time [ Time Frame: 9months ]
    amount of time slept per night


Secondary Outcome Measures :
  1. quality of life [ Time Frame: 9 months ]
    Quality of life as defined by the Ferrans and Powers QOL Inventory


Other Outcome Measures:
  1. Comfort [ Time Frame: 9 months ]
    Self-reported comfort as measured by a Likert scale



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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00218790


Locations
United States, Georgia
Emory affiliated hemodialysis units
Atlanta, Georgia, United States, 30080
Emory University affiliated hemodialysis units
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Kathy P. Parker, PhD,RN,FAAN Emory University, Nell Hodgson Woodruff School of Nursing