Comparison of Dialysis Therapies on Cognitive Function
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Satellite Healthcare.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Satellite Healthcare
Information provided by:
Satellite Healthcare
ClinicalTrials.gov Identifier:
NCT00597103
First received: January 8, 2008
Last updated: NA
Last verified: December 2007
History: No changes posted
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Purpose
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".
| Condition | Intervention |
|---|---|
|
End Stage Renal Disease Chronic Kidney Disease |
Other: Cognitive Function Testing-10 Tests Other: Sleep Assessment Testing Other: Periodic Leg Movement Syndrome Assessment |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Comparison of Dialysis Therapies on Cognitive Function |
Resource links provided by NLM:
MedlinePlus related topics:
Chronic Kidney Disease
Dialysis
Kidney Failure
Restless Legs
Sleep Apnea
U.S. FDA Resources
Further study details as provided by Satellite Healthcare:
Primary Outcome Measures:
- Distribution of cognitive function impairment in ESRD patients undergoing more frequent hemodialysis [ Time Frame: baseline, 4 months and 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Longitudinal analysis of cognitive function over time to test the hypothesis that more frequent hemodialysis contributes to delay in cognitive function impairment [ Time Frame: baseline, 4 months and 12 months ] [ Designated as safety issue: No ]
- To test the hypothesis that nightly or daily hemodialysis treatment can ultimately be proven to be cost effective options by preserving cognitive function. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Influence of cognitive function on survival. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Prevalent patients who have been receiving more frequent dialysis.
|
Other: Cognitive 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
Other: Sleep Assessment Testing
Sleep Assessment will be performed using an "Actiwatch" with subjects wearing the watch for 72 hours continuously
Other: Periodic Leg Movement Syndrome Assessment
Subjects will wear and "Actiwatch" on both legs for three consecutive nights.
|
|
2
Incident patients new to more frequent dialysis
|
Other: Cognitive 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
Other: Sleep Assessment Testing
Sleep Assessment will be performed using an "Actiwatch" with subjects wearing the watch for 72 hours continuously
Other: Periodic Leg Movement Syndrome Assessment
Subjects will wear and "Actiwatch" on both legs for three consecutive nights.
|
|
3
Patients who switch from one more frequent hemodialysis treatment regimen to another more frequent dialysis regimen.
|
Other: Cognitive 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
Other: Sleep Assessment Testing
Sleep Assessment will be performed using an "Actiwatch" with subjects wearing the watch for 72 hours continuously
Other: Periodic Leg Movement Syndrome Assessment
Subjects will wear and "Actiwatch" on both legs for three consecutive nights.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Subjects with Chronic Kidney Disease (CKD) who require renal replacement therapy and who are currently receiving dialysis.
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00597103
Contacts
| Contact: Brigitte Schiller-Moran, MD | 650-404-3640 | schillerb@satellitehealth.com |
| Contact: Sheila Doss, RN, CNN, CCRA | 650-404-3621 | dosss@satellitehealth.com |
Locations
| United States, California | |
| Satellite Healthcare, Inc | Recruiting |
| Mountain View, California, United States, 94041 | |
| Contact: Brigitte Schiller-Moran, MD 650-404-3640 schillerb@satellitehealth.com | |
| Contact: Sheila Doss, RN, CNN, CCRA 650-404-3621 dosss@satellitehealth.com | |
| Principal Investigator: Brigitte Schiller-Moran, MD | |
| WellBound, Inc. | Recruiting |
| Mountain View, California, United States, 94041 | |
| Contact: Brigitte Schiller-Moran, MD 650-404-3640 schillerb@satellitehealth.com | |
| Contact: Sheila Doss, RN, CNN, CCRA 650-404-3621 dosss@satellitehealth.com | |
| Principal Investigator: Brigitte Schiller-Moran, MD | |
Sponsors and Collaborators
Satellite Healthcare
Investigators
| Principal Investigator: | Brigitte Schiller-Moran, MD | Satellite Healthcare, Inc. |
More Information
No publications provided
| Responsible Party: | Brigitte Schiller-Moran MD, Satellite Healthcare, Inc. |
| ClinicalTrials.gov Identifier: | NCT00597103 History of Changes |
| Other Study ID Numbers: | SR016CF |
| Study First Received: | January 8, 2008 |
| Last Updated: | January 8, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Satellite Healthcare:
|
Hemodialysis Frequent Hemodialysis Sleep Apnea Restless Leg Syndrome Cognitive Function |
Additional relevant MeSH terms:
|
Kidney Diseases Kidney Failure, Chronic Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on May 23, 2013