Clinical trial NCT00218790: 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
Overall status: COMPLETED
Phase: NA
Conditions: End-stage Renal Disease
Keywords: Sleep
Renal failure
Dialysis
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2005-09-22
Enrollment: 58
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: total sleep time
timeFrame: 9months
Secondary outcomes:
measure: quality of life
timeFrame: 9 months
Other outcomes:
measure: Comfort
timeFrame: 9 months
Locations:
city: Atlanta
country: United States
facility: Emory affiliated hemodialysis units
state: Georgia
city: Atlanta
country: United States
facility: Emory University affiliated hemodialysis units
state: Georgia
Study officials:
affiliation: Emory University, Nell Hodgson Woodruff School of Nursing
name: Kathy P. Parker, PhD,RN,FAAN
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: Parker KP. Sleep disturbances in dialysis patients. Sleep Med Rev. 2003 Apr;7(2):131-43. doi: 10.1053/smrv.2001.0240.