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NCT00597103 Clinical Trial

Comparison of Dialysis Therapies on Cognitive Function

Chronic Kidney Disease Clinical Trial

Official title:
Comparison of Dialysis Therapies on Cognitive Function

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00597103
Other study ID # SR016CF
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2007
Est. completion date April 5, 2011

Study information
Verified date April 2019
Source Satellite Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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".

Recruitment information / eligibility
Status Completed
Enrollment 17
Est. completion date April 5, 2011
Est. primary completion date April 5, 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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
• Sleep Assessment Testing
Sleep Assessment will be performed using an "Actiwatch" with subjects wearing the watch for 72 hours continuously
• Periodic Leg Movement Syndrome Assessment
Subjects will wear and "Actiwatch" on both legs for three consecutive nights.

Locations
Country Name City State
United States Satellite Healthcare, Inc Mountain View California
United States WellBound, Inc. Mountain View California

Sponsors (1)
Lead Sponsor Collaborator
Satellite Healthcare

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Distribution of cognitive function impairment in ESRD patients undergoing more frequent hemodialysis baseline, 4 months and 12 months
Secondary 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
Secondary 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
Secondary Influence of cognitive function on survival. 12 months
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