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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kathy P. Parker, PhD, RN, FAAN, Emory University
ClinicalTrials.gov Identifier:
NCT00218790
First received: September 16, 2005
Last updated: February 10, 2014
Last verified: September 2005
  Purpose

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 Intervention
End-stage Renal Disease
Procedure: Cool Dialysate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Hemodialysis on the Sleep/Wake Cycle

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • total sleep time [ Time Frame: 9months ] [ Designated as safety issue: No ]
    amount of time slept per night


Secondary Outcome Measures:
  • quality of life [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Quality of life as defined by the Ferrans and Powers QOL Inventory


Other Outcome Measures:
  • Comfort [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    Self-reported comfort as measured by a Likert scale


Enrollment: 58
Study Start Date: April 2003
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218790

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

Publications:
Responsible Party: Kathy P. Parker, PhD, RN, FAAN, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00218790     History of Changes
Other Study ID Numbers: 0602-2002a, R01NR004340
Study First Received: September 16, 2005
Last Updated: February 10, 2014
Health Authority: United States: Federal Government

Keywords provided by Emory University:
Sleep
Renal failure
Dialysis

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Dialysis Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014