Comparison of Dialysis Therapies on Cognitive Function

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Dialysis Therapies on Cognitive Function

Conditions
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End Stage Renal Disease, Chronic Kidney Disease

Intervention / Treatment
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* Other: Cognitive Function Testing-10 Tests
* Other: Sleep Assessment Testing
* Other: Periodic Leg Movement Syndrome Assessment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Prevalent patients who have been receiving more frequent dialysis. | Other: Cognitive Function Testing-10 Tests<br>* 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<br>Other: Sleep Assessment Testing<br>* Sleep Assessment will be performed using an Actiwatch with subjects wearing the watch for 72 hours continuously<br>Other: Periodic Leg Movement Syndrome Assessment<br>* Subjects will wear and Actiwatch on both legs for three consecutive nights.<br>|
| 2<br>Incident patients new to more frequent dialysis | Other: Cognitive Function Testing-10 Tests<br>* 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<br>Other: Sleep Assessment Testing<br>* Sleep Assessment will be performed using an Actiwatch with subjects wearing the watch for 72 hours continuously<br>Other: Periodic Leg Movement Syndrome Assessment<br>* Subjects will wear and Actiwatch on both legs for three consecutive nights.<br>|
| 3<br>Patients who switch from one more frequent hemodialysis treatment regimen to another more frequent dialysis regimen. | Other: Cognitive Function Testing-10 Tests<br>* 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<br>Other: Sleep Assessment Testing<br>* Sleep Assessment will be performed using an Actiwatch with subjects wearing the watch for 72 hours continuously<br>Other: Periodic Leg Movement Syndrome Assessment<br>* Subjects will wear and Actiwatch on both legs for three consecutive nights.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of cognitive function impairment in ESRD patients undergoing more frequent hemodialysis |  | baseline, 4 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, Frequent Hemodialysis, Sleep Apnea, Restless Leg Syndrome, Cognitive Function