End Stage Renal DiseaseNCT00597103
Comparison of Dialysis Therapies on Cognitive Function
An observational study of End Stage Renal Disease and Chronic Kidney Disease, run by Satellite Healthcare at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Chronic Kidney Disease
- What is being tested?
- Cognitive Function Testing-10 Tests, Sleep Assessment Testing and Periodic Leg Movement Syndrome Assessment
- Type of treatment
- Pill or oral medicine
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2007to 5 Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with Chronic Kidney Disease (CKD) who require renal replacement therapy and who are currently receiving dialysis.
Who may be able to join
- 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.
Who cannot join
- Documented non-compliance, defined as missing more than 10% of prescribed treatments during the month prior to the start of the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Satellite Healthcare, Inc
Mountain View, California, 94041
WellBound, Inc.
Mountain View, California, 94041
About this study
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".
- Conditions
- End Stage Renal Disease, Chronic Kidney Disease
- Being tested
- Cognitive Function Testing-10 Tests, Sleep Assessment Testing, Periodic Leg Movement Syndrome Assessment
- Keywords
- Hemodialysis, Frequent Hemodialysis, Sleep Apnea, Restless Leg Syndrome, Cognitive Function
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic, Sleep Apnea Syndromes, Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Function Testing-10 TestsOther
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 TestingOther
Sleep Assessment will be performed using an "Actiwatch" with subjects wearing the watch for 72 hours continuously
Periodic Leg Movement Syndrome AssessmentOther
Subjects will wear and "Actiwatch" on both legs for three consecutive nights.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Prevalent patients who have been receiving more frequent dialysis. Receives: Other: Cognitive Function Testing-10 Tests; Other: Sleep Assessment Testing; Other: Periodic Leg Movement Syndrome Assessment | |
| 2 | Incident patients new to more frequent dialysis Receives: Other: Cognitive Function Testing-10 Tests; Other: Sleep Assessment Testing; Other: Periodic Leg Movement Syndrome Assessment | |
| 3 | Patients who switch from one more frequent hemodialysis treatment regimen to another more frequent dialysis regimen. Receives: Other: Cognitive Function Testing-10 Tests; Other: Sleep Assessment Testing; Other: Periodic Leg Movement Syndrome Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of cognitive function impairment in ESRD patients undergoing more frequent hemodialysis
Measured: baseline, 4 months and 12 months
Secondary outcomes (3)
Longitudinal analysis of cognitive function over time to test the hypothesis that more frequent hemodialysis contributes to delay in cognitive function impairment
Measured: 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.
Measured: 12 months
Influence of cognitive function on survival.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startDec 2007
- Primary completion5 Apr 2011
- Study completion5 Apr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Satellite Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brigitte Schiller-Moran, MD, Principal investigator, Satellite Healthcare, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597103
- Sponsor's protocol ID
- SR016CF
- Status last verified
- Apr 2019
- First submitted
- 8 Jan 2008
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dialysis Therapies on Cognitive Function
- ClinicalTrials.gov ID
- NCT00597103
- Acronym / sponsor ID
- SR016CF
- Conditions
- End Stage Renal Disease, Chronic Kidney Disease
- Keywords
- Hemodialysis, Frequent Hemodialysis, Sleep Apnea, Restless Leg Syndrome, Cognitive Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Satellite HealthcareUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- 5 Apr 2011 (actual)
- Study completion
- 5 Apr 2011 (actual)
- First posted
- 17 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Cognitive Function Testing-10 Tests, Other: Sleep Assessment Testing, Other: Periodic Leg Movement Syndrome AssessmentPrevalent patients who have been receiving more frequent dialysis. |
| 2 | – | Other: Cognitive Function Testing-10 Tests, Other: Sleep Assessment Testing, Other: Periodic Leg Movement Syndrome AssessmentIncident patients new to more frequent dialysis |
| 3 | – | Other: Cognitive Function Testing-10 Tests, Other: Sleep Assessment Testing, Other: Periodic Leg Movement Syndrome AssessmentPatients who switch from one more frequent hemodialysis treatment regimen to another more frequent dialysis regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with Chronic Kidney Disease (CKD) who require renal replacement therapy and who are currently receiving dialysis.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Documented non-compliance, defined as missing more than 10% of prescribed treatments during the month prior to the start of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Function Testing-10 TestsTrailmaking 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 | 1, 2, 3 |
| Sleep Assessment TestingSleep Assessment will be performed using an "Actiwatch" with subjects wearing the watch for 72 hours continuously | Other | 1, 2, 3 |
| Periodic Leg Movement Syndrome AssessmentSubjects will wear and "Actiwatch" on both legs for three consecutive nights. | Other | 1, 2, 3 |
Primary outcome
Distribution of cognitive function impairment in ESRD patients undergoing more frequent hemodialysis
Time frame: baseline, 4 months and 12 months
3 secondary outcomes
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
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
Influence of cognitive function on survival.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitte Schiller-Moran, MD principal investigator
Satellite Healthcare, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease and Chronic Kidney Disease, run by Satellite Healthcare at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of cognitive function impairment in ESRD patients undergoing more frequent hemodialysis (time frame: baseline, 4 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.