End-stage Renal Disease
Conditions
Keywords
Sleep, Renal failure, Dialysis
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.
Interventions
PROCEDURECool Dialysate
Decreased temperature of the dialysis bath
Sponsors
National Institute of Nursing Research (NINR)
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| total sleep time | 9months | amount of time slept per night |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| quality of life | 9 months | Quality of life as defined by the Ferrans and Powers QOL Inventory |
Other
| Measure | Time frame | Description |
|---|---|---|
| Comfort | 9 months | Self-reported comfort as measured by a Likert scale |
Countries
United States
Outcome results
None listed