End-stage Renal DiseaseNCT00218790
The Effects of Cool Dialysate on the Sleep/Wake Cycle in Patients on Chronic Hemodialysis - "The Sleep Cool Study"
A study testing Cool Dialysate in people with End-stage Renal Disease, run by Emory University at 2 sites in United States.
Trial summary
A major component of this study is to test a novel application for a safe, non-pharmacologic, cost-effective intervention that is already in use in clinical practice - using cool dialysate during hemodialysis to help stabilize the sleep/wake cycle of chronic hemodialysis patients. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- Cool Dialysate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2003to Apr 2008
- Phase
- Interventional
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All races, cause of renal failure is diabetes, hypertension, glomerulonephritis, or polycystic kidney disease; ability to read and write in English; clinically stable.
Who cannot join
- Current use of sleeping medication; history of alcoholism or drug abuse; brain disease; severe hypertension; severe heart disease; low functional level
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory affiliated hemodialysis units
Atlanta, Georgia, 30080
Emory University affiliated hemodialysis units
Atlanta, Georgia, 30322
About this study
Official title: The Effects of Hemodialysis on the Sleep/Wake Cycle
A major component of this study is to test a novel application for a safe, non-pharmacologic, cost-effective intervention that is already in use in clinical practice - using cool dialysate during hemodialysis to help stabilize the sleep/wake cycle of chronic hemodialysis patients. We will also evaluate its effects on selected sleep-related physiologic, psychological, behavioral, and general health outcomes.
Read the detailed description
Preliminary results demonstrate that, after one treatment, using cool dialysate instead of warm dialysate markedly normalized the rhythm of body temperature and improved indices on nocturnal sleep quantity and quality. Therefore, a major component of this study is to test a novel application for a safe, non-pharmacologic, cost-effective intervention that is alreay in use in clinical practice - using cool dialysate during hemodialysis to help stabilize the sleep/wake cycle of chronic hemodialysis patients. We will also evaluate its effects on selected sleep-related physiologic, psychological, behavioral, and general health outcomes.
To test the efficacy of this intervention, a randomized, single-blinded, pretest-posttest, control group design is being used. The major independent variable is dialysate temperature. The major dependent variables are measures of sleep, body temperature, rest/activity patterns, and general health outcomes.
- Conditions
- End-stage Renal Disease
- Being tested
- Cool Dialysate
- Keywords
- Sleep, Renal failure, Dialysis
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cool DialysateProcedure or surgery
Decreased temperature of the dialysis bath
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group received standard dialysis at a temperature of 37 degrees Celcius |
| Experimental group | Experimental | Subjects in the experimental group received cool dialysate during treatment Receives: Procedure: Cool Dialysate |
What is being measured
The primary outcome is the main question the study is designed to answer.
total sleep time
amount of time slept per night
Measured: 9months
Secondary outcomes (1)
quality of life
Quality of life as defined by the Ferrans and Powers QOL Inventory
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startApr 2003
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Kathy P. Parker, PhD, RN, FAAN, Emory University
- Investigators
- Kathy P. Parker, PhD,RN,FAAN, Principal investigator, Emory University, Nell Hodgson Woodruff School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218790
- Sponsor's protocol ID
- 0602-2002a
- Other IDs
- R01NR004340
- Status last verified
- Sep 2005
- First submitted
- 16 Sep 2005
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Parker KP, Bliwise DL, Bailey JL, Rye DB. Polysomnographic measures of nocturnal sleep in patients on chronic, intermittent daytime haemodialysis vs those with chronic kidney disease. Nephrol Dial Transplant. 2005 Jul;20(7):1422-8. doi: 10.1093/ndt/gfh816. Epub 2005 Apr 19.
PubMed 15840682Lee KA, Landis C, Chasens ER, Dowling G, Merritt S, Parker KP, Redeker N, Richards KC, Rogers AE, Shaver JF, Umlauf MG, Weaver TE. Sleep and chronobiology: recommendations for nursing education. Nurs Outlook. 2004 May-Jun;52(3):126-33. doi: 10.1016/j.outlook.2003.12.002. No abstract available.
PubMed 15197361Parker KP, Kutner NG, Bliwise DL, Bailey JL, Rye DB. Nocturnal sleep, daytime sleepiness, and quality of life in stable patients on hemodialysis. Health Qual Life Outcomes. 2003 Nov 21;1:68. doi: 10.1186/1477-7525-1-68.
PubMed 14633280Parker KP. Sleep disturbances in dialysis patients. Sleep Med Rev. 2003 Apr;7(2):131-43. doi: 10.1053/smrv.2001.0240.
PubMed 12628214
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Hemodialysis on the Sleep/Wake Cycle
- ClinicalTrials.gov ID
- NCT00218790
- Acronym / sponsor ID
- 0602-2002a
- Conditions
- End-stage Renal Disease
- Keywords
- Sleep, Renal failure, Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Apr 2003
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 22 Sep 2005 (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.
A major component of this study is to test a novel application for a safe, non-pharmacologic, cost-effective intervention that is already in use in clinical practice - using cool dialysate during hemodialysis to help stabilize the sleep/wake cycle of chronic hemodialysis patients. We will also evaluate its effects on selected sleep-related physiologic, psychological, behavioral, and general health outcomes.
Detailed description
Preliminary results demonstrate that, after one treatment, using cool dialysate instead of warm dialysate markedly normalized the rhythm of body temperature and improved indices on nocturnal sleep quantity and quality. Therefore, a major component of this study is to test a novel application for a safe, non-pharmacologic, cost-effective intervention that is alreay in use in clinical practice - using cool dialysate during hemodialysis to help stabilize the sleep/wake cycle of chronic hemodialysis patients. We will also evaluate its effects on selected sleep-related physiologic, psychological, behavioral, and general health outcomes.
To test the efficacy of this intervention, a randomized, single-blinded, pretest-posttest, control group design is being used. The major independent variable is dialysate temperature. The major dependent variables are measures of sleep, body temperature, rest/activity patterns, and general health outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group received standard dialysis at a temperature of 37 degrees Celcius |
| Experimental group | Experimental | Procedure: Cool DialysateSubjects in the experimental group received cool dialysate during treatment |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All races, cause of renal failure is diabetes, hypertension, glomerulonephritis, or polycystic kidney disease; ability to read and write in English; clinically stable.
Key exclusion criteria (1 listed)
- Current use of sleeping medication; history of alcoholism or drug abuse; brain disease; severe hypertension; severe heart disease; low functional level
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 |
|---|---|---|
| Cool DialysateDecreased temperature of the dialysis bath | Procedure or surgery | Experimental group |
Primary outcome
total sleep time
Time frame: 9months
amount of time slept per night
1 secondary outcome
quality of life
Time frame: 9 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 12 Feb 2014.
- Background: PubMed 15840682Parker KP, Bliwise DL, Bailey JL, Rye DB. Polysomnographic measures of nocturnal sleep in patients on chronic, intermittent daytime haemodialysis vs those with chronic kidney disease. Nephrol Dial Transplant. 2005 Jul;20(7):1422-8. doi: 10.1093/ndt/gfh816. Epub 2005 Apr 19.
- Background: PubMed 15197361Lee KA, Landis C, Chasens ER, Dowling G, Merritt S, Parker KP, Redeker N, Richards KC, Rogers AE, Shaver JF, Umlauf MG, Weaver TE. Sleep and chronobiology: recommendations for nursing education. Nurs Outlook. 2004 May-Jun;52(3):126-33. doi: 10.1016/j.outlook.2003.12.002. No abstract available.
- Background: PubMed 14633280Parker KP, Kutner NG, Bliwise DL, Bailey JL, Rye DB. Nocturnal sleep, daytime sleepiness, and quality of life in stable patients on hemodialysis. Health Qual Life Outcomes. 2003 Nov 21;1:68. doi: 10.1186/1477-7525-1-68.
- Background: PubMed 12628214Parker KP. Sleep disturbances in dialysis patients. Sleep Med Rev. 2003 Apr;7(2):131-43. doi: 10.1053/smrv.2001.0240.
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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.
Kathy P. Parker, PhD,RN,FAAN principal investigator
Emory University, Nell Hodgson Woodruff School of Nursing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cool Dialysate in people with End-stage Renal Disease, run by Emory University 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 1 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 12 Feb 2014. 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?
total sleep time (time frame: 9months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00218790, which also lists 4 linked publications.
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 12 Feb 2014.