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

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00218790
• Collaborator: National Institute of Nursing Research (NINR) (NIH)
• Enrollment: 58
• Locations: 2
• Arms: 2
• Duration (Months): 60
• Patients Per Site: 29
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Apr 1, 2003
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Apr 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. total sleep time [9months]

   amount of time slept per night

Secondary Outcome Measures

1. quality of life [9 months]

   Quality of life as defined by the Ferrans and Powers QOL Inventory

Other Outcome Measures

1. Comfort [9 months]

   Self-reported comfort as measured by a Likert scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Emory affiliated hemodialysis units	Atlanta	Georgia	United States	30080
2	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Review.
• 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. Epub 2005 Apr 19.
• 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.
• Parker KP. Sleep disturbances in dialysis patients. Sleep Med Rev. 2003 Apr;7(2):131-43. Review.

• Responsible Party: Kathy P. Parker, PhD, RN, FAAN, Principal Investigator, Emory University
• ClinicalTrials.gov Identifier: NCT00218790
• Other Study ID Numbers: 0602-2002a; R01NR004340
• First Posted: Sep 22, 2005
• Last Update Posted: Feb 12, 2014
• Last Verified: Sep 1, 2005

• Keywords provided by Kathy P. Parker, PhD, RN, FAAN, Principal Investigator, Emory University: Sleep; Renal failure; Dialysis
• Additional relevant MeSH terms: Kidney Failure, Chronic; Dialysis Solutions

Study Results

No Results Posted as of Feb 12, 2014