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Comparison of Dialysis Therapies on Cognitive Function

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ClinicalTrials.gov Identifier: NCT00597103
Recruitment Status : Unknown
Verified December 2007 by Satellite Healthcare.
Recruitment status was:  Recruiting
First Posted : January 17, 2008
Last Update Posted : January 17, 2008
Sponsor:
Information provided by:

Study Description
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".

Condition or disease Intervention/treatment
End Stage Renal Disease Chronic Kidney Disease Other: Cognitive Function Testing-10 Tests Other: Sleep Assessment Testing Other: Periodic Leg Movement Syndrome Assessment

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison of Dialysis Therapies on Cognitive Function
Study Start Date : December 2007
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Distribution of cognitive function impairment in ESRD patients undergoing more frequent hemodialysis [ Time Frame: baseline, 4 months and 12 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Influence of cognitive function on survival. [ Time Frame: 12 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Brigitte Schiller-Moran MD, Satellite Healthcare, Inc.
ClinicalTrials.gov Identifier: NCT00597103     History of Changes
Other Study ID Numbers: SR016CF
First Posted: January 17, 2008    Key Record Dates
Last Update Posted: January 17, 2008
Last Verified: December 2007

Keywords provided by Satellite Healthcare:
Hemodialysis
Frequent Hemodialysis
Sleep Apnea
Restless Leg Syndrome
Cognitive Function

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency