Comparison of Dialysis Therapies on Cognitive Function
April 16, 2019 updated by: Satellite Healthcare
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".
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
17
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Mountain View, California, United States, 94041
- WellBound, Inc.
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Mountain View, California, United States, 94041
- Satellite Healthcare, Inc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Subjects with Chronic Kidney Disease (CKD) who require renal replacement therapy and who are currently receiving dialysis.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
Prevalent patients who have been receiving more frequent dialysis.
|
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
Sleep Assessment will be performed using an "Actiwatch" with subjects wearing the watch for 72 hours continuously
Subjects will wear and "Actiwatch" on both legs for three consecutive nights.
|
|
2
Incident patients new to more frequent dialysis
|
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
Sleep Assessment will be performed using an "Actiwatch" with subjects wearing the watch for 72 hours continuously
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.
|
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
Sleep Assessment will be performed using an "Actiwatch" with subjects wearing the watch for 72 hours continuously
Subjects will wear and "Actiwatch" on both legs for three consecutive nights.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Distribution of cognitive function impairment in ESRD patients undergoing more frequent hemodialysis
Time Frame: baseline, 4 months and 12 months
|
baseline, 4 months and 12 months
|
Secondary Outcome Measures
Outcome 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
Time Frame: baseline, 4 months and 12 months
|
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.
Time Frame: 12 months
|
12 months
|
|
Influence of cognitive function on survival.
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brigitte Schiller-Moran, MD, Satellite Healthcare, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
April 5, 2011
Study Completion (Actual)
April 5, 2011
Study Registration Dates
First Submitted
January 8, 2008
First Submitted That Met QC Criteria
January 8, 2008
First Posted (Estimate)
January 17, 2008
Study Record Updates
Last Update Posted (Actual)
April 18, 2019
Last Update Submitted That Met QC Criteria
April 16, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SR016CF
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.