Chronic Kidney DiseaseCRICNCT00817674
Sleep Disturbances as a Non-traditional Risk Factor in CKD-Actigraphy
An observational study of Chronic Kidney Disease and Sleep Loss, run by University of Chicago at 1 site in United States.
Trial summary
To test if usual at home night time sleep duration as measured with activity monitors and questionnaires will predict changes in kidney function as measured by kidney filtration rate and of cardiovascular function as measured by C-reactive protein in the blood. Read more about this study
- Who is it for?
- Ages 21 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, Sleep Loss
- How many people
- 353 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Oct 2010
- 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 21 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: CKD subjects; healthy volunteers
Who may be able to join
- Mild to Moderate CKD
- Healthy controls age and gender matched to CKD subjects
- Regular bedtimes of at least 6h/night, sedentary lifestyle
Who cannot join
- Diabetes
- Current or previous dialysis for more than 1 month
- Uncontrolled hypertension
- Heart failure
- Liver disease
- HIV
Show all 13Show fewer
- Hemoglobin < 10.5 g/dl
- Treatment with EProcrit, Epogen, or Aranesp
- Bone or organ transplant,
- Use of immunosuppressive drugs within past 6 months
- Current oral contraceptive use
- Current pregnancy
- Chemotherapy for malignancy within past 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep Disturbances as a Non-traditional Risk Factor in CKD-Wrist Actigraphy
To test if usual at home night time sleep duration as measured with activity monitors and questionnaires will predict changes in kidney function as measured by kidney filtration rate and of cardiovascular function as measured by C-reactive protein in the blood. The study will explore the role of decreased sleep time or decreased sleep quality as a non-traditional risk factor for the progression of CKD and for the development of cardiovascular disease in CKD.
- Conditions
- Chronic Kidney Disease, Sleep Loss
- Keywords
- CKD, Kidney Disease, poor sleep, CKD progression
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | CKD subjects | |
| 2 | Healthy Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
CKD progression as measured by changes in GFR and cardiovascular risk as measured by CRP over a 5 year period
Measured: 5 years
Secondary outcomes (1)
insulin resistance
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startNov 2007
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois Chicago, Case Western Reserve University
- Responsible party
- Sponsor
- Investigators
- Eve Van Cauter, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817674
- Sponsor's protocol ID
- #14081A
- Other IDs
- 5R01DK071696
- Acronym
- CRIC
- Status last verified
- Sep 2013
- First submitted
- 5 Jan 2009
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disturbances as a Non-traditional Risk Factor in CKD-Wrist Actigraphy
- ClinicalTrials.gov ID
- NCT00817674
- Acronym / sponsor ID
- CRIC / #14081A
- Conditions
- Chronic Kidney Disease, Sleep Loss
- Keywords
- CKD, Kidney Disease, poor sleep, CKD progression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- University of Illinois Chicago, Case Western Reserve University
- Study start
- Nov 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 6 Jan 2009 (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.
To test if usual at home night time sleep duration as measured with activity monitors and questionnaires will predict changes in kidney function as measured by kidney filtration rate and of cardiovascular function as measured by C-reactive protein in the blood. The study will explore the role of decreased sleep time or decreased sleep quality as a non-traditional risk factor for the progression of CKD and for the development of cardiovascular disease in CKD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –CKD subjects |
| 2 | – | –Healthy Controls |
Who may qualify
- Ages
- 21 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- CKD subjects; healthy volunteers
Key inclusion criteria (3 listed)
- Mild to Moderate CKD
- Healthy controls age and gender matched to CKD subjects
- Regular bedtimes of at least 6h/night, sedentary lifestyle
Key exclusion criteria (13 listed)
- Diabetes
- Current or previous dialysis for more than 1 month
- Uncontrolled hypertension
- Heart failure
- Liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CKD progression as measured by changes in GFR and cardiovascular risk as measured by CRP over a 5 year period
Time frame: 5 years
1 secondary outcome
insulin resistance
Time frame: 5 years
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 5 Sep 2013.
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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.
Eve Van Cauter, PhD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and Sleep Loss, run by University of Chicago at 1 site 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 3 inclusion and 13 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 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
CKD progression as measured by changes in GFR and cardiovascular risk as measured by CRP over a 5 year period (time frame: 5 years). 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 5 Sep 2013.