Chronic Kidney Disease, End Stage Renal Disease
Conditions
Keywords
Hemodialysis, Frequent Hemodialysis, Sleep Apnea, Restless Leg Syndrome, Cognitive Function
Brief summary
This study will evaluate the effects of more frequent dialysis on cognitive function including the assessment of sleep apnea and restless legs. Our hypothesis is that more frequent dialysis improves cognitive function and may have important implications on clinical care of ESRD patients and help to emphasize the need for treatments that will allow patients to live with dialysis rather than live for dialysis.
Interventions
OTHERCognitive Function Testing-10 Tests
Trailmaking A, Trailmaking B, Rey Auditory Verbal Learning, Letter Number Sequencing, Digit Symbol Substitution, Grooved Pegboard, Controlled Oral Word Association, Beck Depression Index, Feeling Thermometer, Modified Mini-Mental Status
OTHERSleep Assessment Testing
Sleep Assessment will be performed using an Actiwatch with subjects wearing the watch for 72 hours continuously
OTHERPeriodic Leg Movement Syndrome Assessment
Subjects will wear and Actiwatch on both legs for three consecutive nights.
Sponsors
Satellite Healthcare
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of ESRD * Age 18 years or greater * Ability to understand and a willingness to sign an informed consent statement and a Health Insurance Portability and Accountability Act of 1996 (HIPPA) authorization statement. * Expected survival of at least one year.
Exclusion criteria
* Documented non-compliance, defined as missing more than 10% of prescribed treatments during the month prior to the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distribution of cognitive function impairment in ESRD patients undergoing more frequent hemodialysis | baseline, 4 months and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Longitudinal analysis of cognitive function over time to test the hypothesis that more frequent hemodialysis contributes to delay in cognitive function impairment | baseline, 4 months and 12 months |
| To test the hypothesis that nightly or daily hemodialysis treatment can ultimately be proven to be cost effective options by preserving cognitive function. | 12 months |
| Influence of cognitive function on survival. | 12 months |
Countries
United States
Outcome results
None listed