Comparison of Dialysis Therapies on Cognitive Function - Full Text View

Sponsored by:	Satellite Healthcare
Information provided by:	Satellite Healthcare
ClinicalTrials.gov Identifier:	NCT00597103

Purpose

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	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:	Case Control, Prospective
Official Title:	Comparison of Dialysis Therapies on Cognitive Function

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Kidney Failure Restless Legs

U.S. FDA Resources

Further study details as provided by Satellite Healthcare:

Primary Outcome Measures:

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:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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 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
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

No publications provided

Responsible Party:	Satellite Healthcare, Inc. ( Brigitte Schiller-Moran MD )
Study ID Numbers:	SR016CF
Study First Received:	January 8, 2008
Last Updated:	January 8, 2008
ClinicalTrials.gov Identifier:	NCT00597103 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Satellite Healthcare:

Hemodialysis
Frequent Hemodialysis
Sleep Apnea
Restless Leg Syndrome
Cognitive Function

Study placed in the following topic categories:

Renal Insufficiency
Sleep Apnea Syndromes
Urologic Diseases
Renal Insufficiency, Chronic
Apnea

Restless Legs Syndrome
Kidney Failure, Chronic
Psychomotor Agitation
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on September 11, 2009