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OpenTrials
Completed

NCT Number: NCT00597103

Comparison of Dialysis Therapies on Cognitive Function

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".

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Key information

Conditions

End Stage Renal Disease Apnea Chronic Disease Chronic Kidney Disease Disease Attributes Dyssomnias Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Mental Disorders Nervous System Diseases Parasomnias Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Respiration Disorders Respiratory Tract Diseases Restless Legs Syndrome Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Satellite Healthcare, Inc, Mountain View, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Function Testing-10 Tests

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

Other

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

Periodic Leg Movement Syndrome Assessment

Other

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

Primary outcomes

  1. Distribution of cognitive function impairment in ESRD patients undergoing more frequent hemodialysis

    Time frame: baseline, 4 months and 12 months

Secondary outcomes

  1. 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

  2. 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

  3. Influence of cognitive function on survival.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Satellite Healthcare

Other

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jan 17, 2008
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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