Comparison of Dialysis Therapies on Cognitive Function

Completed

• Conditions: End Stage Renal Disease; Chronic Kidney Disease
• Interventions: Other: Cognitive Function Testing-10 Tests; Other: Sleep Assessment Testing; Other: Periodic Leg Movement Syndrome Assessment

• Registration Number: NCT00597103
• Lead Sponsor: Satellite Healthcare

Brief 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".

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-08
• Study First Submitted QC: 2008-01-08
• Study First Posted: 2008-01-17
• Primary Completion: 2011-04-05
• Study Completion: 2011-04-05
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2	Periodic Leg Movement Syndrome Assessment	Incident patients new to more frequent dialysis
1	Sleep Assessment Testing	Prevalent patients who have been receiving more frequent dialysis.
1	Cognitive Function Testing-10 Tests	Prevalent patients who have been receiving more frequent dialysis.
2	Cognitive Function Testing-10 Tests	Incident patients new to more frequent dialysis
2	Sleep Assessment Testing	Incident patients new to more frequent dialysis
1	Periodic Leg Movement Syndrome Assessment	Prevalent patients who have been receiving more frequent dialysis.
3	Cognitive Function Testing-10 Tests	Patients who switch from one more frequent hemodialysis treatment regimen to another more frequent dialysis regimen.
3	Sleep Assessment Testing	Patients who switch from one more frequent hemodialysis treatment regimen to another more frequent dialysis regimen.
3	Periodic Leg Movement Syndrome Assessment	Patients who switch from one more frequent hemodialysis treatment regimen to another more frequent dialysis regimen.

Primary Outcome Measures

Name	Time	Method
Distribution of cognitive function impairment in ESRD patients undergoing more frequent hemodialysis	baseline, 4 months and 12 months

Secondary Outcome Measures

Name	Time	Method
Influence of cognitive function on survival.	12 months
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
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

Trial Locations

Locations (2)

Satellite Healthcare, Inc; 🇺🇸 Mountain View, California, United States

WellBound, Inc.; 🇺🇸 Mountain View, California, United States