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

First Received on January 8, 2008.  
No Changes Posted
This Clinical Trial Sponsored By: Satellite Healthcare
Information provided by: Satellite Healthcare
ClinicalTrials.gov Identifier: NCT00597103
 

Purpose for Clinical Trial

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 Study 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 For Clinical Trial:

  • 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 For Clinical Trial:

  • 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 Study 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

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