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

The Effects of Hemodialysis on the Sleep/Wake Cycle

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.

Study Overview

• Status: Completed
• Conditions: End-stage Renal Disease
• Intervention / Treatment: Procedure: Cool Dialysate

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
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30080
      • Emory affiliated hemodialysis units
    • Atlanta, Georgia, United States, 30322
      • Emory University affiliated hemodialysis units

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort	Self-reported comfort as measured by a Likert scale	9 months

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Kathy P. Parker, PhD,RN,FAAN, Emory University, Nell Hodgson Woodruff School of Nursing

Publications and helpful links

General Publications

• Parker KP, Bliwise DL, Bailey JL, Rye DB. Polysomnographic measures of nocturnal sleep in patients on chronic, intermittent daytime haemodialysis vs those with chronic kidney disease. Nephrol Dial Transplant. 2005 Jul;20(7):1422-8. doi: 10.1093/ndt/gfh816. Epub 2005 Apr 19.
• Lee KA, Landis C, Chasens ER, Dowling G, Merritt S, Parker KP, Redeker N, Richards KC, Rogers AE, Shaver JF, Umlauf MG, Weaver TE. Sleep and chronobiology: recommendations for nursing education. Nurs Outlook. 2004 May-Jun;52(3):126-33. doi: 10.1016/j.outlook.2003.12.002. No abstract available.
• Parker KP, Kutner NG, Bliwise DL, Bailey JL, Rye DB. Nocturnal sleep, daytime sleepiness, and quality of life in stable patients on hemodialysis. Health Qual Life Outcomes. 2003 Nov 21;1:68. doi: 10.1186/1477-7525-1-68.
• Parker KP. Sleep disturbances in dialysis patients. Sleep Med Rev. 2003 Apr;7(2):131-43. doi: 10.1053/smrv.2001.0240.

Study record dates

Study Major Dates

• Study Start: April 1, 2003
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: September 16, 2005
• First Submitted That Met QC Criteria: September 16, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): February 12, 2014
• Last Update Submitted That Met QC Criteria: February 10, 2014
• Last Verified: September 1, 2005

More Information

Terms related to this study

• Keywords: Sleep; Dialysis; Renal failure
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Pharmaceutical Solutions; Dialysis Solutions
• Other Study ID Numbers: 0602-2002a; R01NR004340 (U.S. NIH Grant/Contract)