Comparison of Dialysis Therapies on Cognitive Function

NCT ID: NCT00597103

Last Updated: 2019-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2011-04-05

Brief Summary

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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".

Detailed Description

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Conditions

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End Stage Renal Disease Chronic Kidney Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Prevalent patients who have been receiving more frequent dialysis.

Cognitive Function Testing-10 Tests

Intervention Type 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

Sleep Assessment Testing

Intervention Type OTHER

Sleep Assessment will be performed using an "Actiwatch" with subjects wearing the watch for 72 hours continuously

Periodic Leg Movement Syndrome Assessment

Intervention Type OTHER

Subjects will wear and "Actiwatch" on both legs for three consecutive nights.

2

Incident patients new to more frequent dialysis

Cognitive Function Testing-10 Tests

Intervention Type 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

Sleep Assessment Testing

Intervention Type OTHER

Sleep Assessment will be performed using an "Actiwatch" with subjects wearing the watch for 72 hours continuously

Periodic Leg Movement Syndrome Assessment

Intervention Type OTHER

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.

Cognitive Function Testing-10 Tests

Intervention Type 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

Sleep Assessment Testing

Intervention Type OTHER

Sleep Assessment will be performed using an "Actiwatch" with subjects wearing the watch for 72 hours continuously

Periodic Leg Movement Syndrome Assessment

Intervention Type OTHER

Subjects will wear and "Actiwatch" on both legs for three consecutive nights.

Interventions

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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

Intervention Type OTHER

Sleep Assessment Testing

Sleep Assessment will be performed using an "Actiwatch" with subjects wearing the watch for 72 hours continuously

Intervention Type OTHER

Periodic Leg Movement Syndrome Assessment

Subjects will wear and "Actiwatch" on both legs for three consecutive nights.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Satellite Healthcare

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brigitte Schiller-Moran, MD

Role: PRINCIPAL_INVESTIGATOR

Satellite Healthcare, Inc.

Locations

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Satellite Healthcare, Inc

Mountain View, California, United States

Site Status

WellBound, Inc.

Mountain View, California, United States

Site Status

Countries

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United States

Other Identifiers

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SR016CF

Identifier Type: -

Identifier Source: org_study_id

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