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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".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Prevalent patients who have been receiving more frequent dialysis. |
| |
| 2 | Incident patients new to more frequent dialysis |
| |
| 3 | Patients who switch from one more frequent hemodialysis treatment regimen to another more frequent dialysis regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Function Testing-10 Tests | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of cognitive function impairment in ESRD patients undergoing more frequent hemodialysis | baseline, 4 months and 12 months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with Chronic Kidney Disease (CKD) who require renal replacement therapy and who are currently receiving dialysis.
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| Name | Affiliation | Role |
|---|---|---|
| Brigitte Schiller-Moran, MD | Satellite Healthcare, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Satellite Healthcare, Inc | Mountain View | California | 94041 | United States | ||
| WellBound, Inc. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051436 | Renal Insufficiency, Chronic |
| D012891 | Sleep Apnea Syndromes |
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Sleep Assessment Testing | Other | Sleep Assessment will be performed using an "Actiwatch" with subjects wearing the watch for 72 hours continuously |
|
| Periodic Leg Movement Syndrome Assessment | Other | Subjects will wear and "Actiwatch" on both legs for three consecutive nights. |
|
| 12 months |
| Influence of cognitive function on survival. | 12 months |
| Mountain View |
| California |
| 94041 |
| United States |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D020447 | Parasomnias |
| D001523 | Mental Disorders |