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

Primary Purpose

End-stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cool Dialysate
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-stage Renal Disease focused on measuring Sleep, Renal failure, Dialysis

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory affiliated hemodialysis units
  • Emory University affiliated hemodialysis units

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Experimental group

Arm Description

The control group received standard dialysis at a temperature of 37 degrees Celcius

Subjects in the experimental group received cool dialysate during treatment

Outcomes

Primary Outcome Measures

total sleep time
amount of time slept per night

Secondary Outcome Measures

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

Full Information

First Posted
September 16, 2005
Last Updated
February 10, 2014
Sponsor
Emory University
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT00218790
Brief Title
The Effects of Cool Dialysate on the Sleep/Wake Cycle in Patients on Chronic Hemodialysis - "The Sleep Cool Study"
Official Title
The Effects of Hemodialysis on the Sleep/Wake Cycle
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease
Keywords
Sleep, Renal failure, Dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group received standard dialysis at a temperature of 37 degrees Celcius
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Subjects in the experimental group received cool dialysate during treatment
Intervention Type
Procedure
Intervention Name(s)
Cool Dialysate
Intervention Description
Decreased temperature of the dialysis bath
Primary Outcome Measure Information:
Title
total sleep time
Description
amount of time slept per night
Time Frame
9months
Secondary Outcome Measure Information:
Title
quality of life
Description
Quality of life as defined by the Ferrans and Powers QOL Inventory
Time Frame
9 months
Other Pre-specified Outcome Measures:
Title
Comfort
Description
Self-reported comfort as measured by a Likert scale
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathy P. Parker, PhD,RN,FAAN
Organizational Affiliation
Emory University, Nell Hodgson Woodruff School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory affiliated hemodialysis units
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
Emory University affiliated hemodialysis units
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15840682
Citation
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.
Results Reference
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PubMed Identifier
15197361
Citation
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.
Results Reference
background
PubMed Identifier
14633280
Citation
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.
Results Reference
background
PubMed Identifier
12628214
Citation
Parker KP. Sleep disturbances in dialysis patients. Sleep Med Rev. 2003 Apr;7(2):131-43. doi: 10.1053/smrv.2001.0240.
Results Reference
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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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