Chronic Kidney DiseaseCRICNCT00817427
Sleep Disturbances as a Risk Factor in Chronic Kidney Disease
A study testing CKD- sleep extension in people with Chronic Kidney Disease, run by University of Chicago at 1 site in United States.
Trial summary
This study is designed to determine if either short night time sleep or poor night time sleep could be a risk factor for increasing the rate at which kidney function deteriorates in persons with mild to moderate kidney disease. 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
- What is being tested?
- CKD- sleep extension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jul 2011
- 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 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 Disturbance as a Non-Traditional Risk Factor in CKD
This study is designed to determine if either short night time sleep or poor night time sleep could be a risk factor for increasing the rate at which kidney function deteriorates in persons with mild to moderate kidney disease.
- Conditions
- Chronic Kidney Disease
- Being tested
- Controls Short sleep, CKD- sleep extension
- Keywords
- Chronic Kidney Disease, Poor sleep, CKD, Kidney Failure
- Medical subject headings
- Renal Insufficiency, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controls Short sleepOther
Also called Sleep intervention
Healthy control subject's bedtime will be decreased by 2 hours/night with acoustic sleep disruption
CKD- sleep extensionOther
Also called Sleep intervention
Sleep will be increased by 2 hours each night for 3 nights
| Study group | Role | What they receive |
|---|---|---|
| Baseline | No intervention | CKD subjects and healthy, matched controls will have measures of cardiovascular function (BP, HR) measure of hormonal fluid balance (renin/aldosterone) measure and measures of glucose metabolism (response to glucose load and over 24 hr profile) with 3 days of habitual sleep time |
| CKD- Sleep extension | Experimental | Measures as in baseline but with bed time increased by 2 hours Receives: Other: CKD- sleep extension |
| Controls short sleep | Experimental | Measures as in baseline but with sleep disruption Receives: Other: Controls Short sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of chronobiological profiles of renin/aldosterone, sympatho-vagal balance and CV function in CKD subjects to controls at baseline and after extended sleep in CKD subjects and after decreased time and quality of sleep in control subjects.
Measured: Immediately after intervention.
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 startOct 2008
- Primary completionJun 2011
- Study completionJul 2011
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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eve Van Cauter, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817427
- Sponsor's protocol ID
- #14075A
- Other IDs
- 5RO1DK71696-4, 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 Disturbance as a Non-Traditional Risk Factor in CKD
- ClinicalTrials.gov ID
- NCT00817427
- Acronym / sponsor ID
- CRIC / #14075A
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, Poor sleep, CKD, Kidney Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (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.
This study is designed to determine if either short night time sleep or poor night time sleep could be a risk factor for increasing the rate at which kidney function deteriorates in persons with mild to moderate kidney disease.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Baseline | No intervention | –CKD subjects and healthy, matched controls will have measures of cardiovascular function (BP, HR) measure of hormonal fluid balance (renin/aldosterone) measure and measures of glucose metabolism (response to glucose load and over 24 hr profile) with 3 days of habitual sleep time |
| CKD- Sleep extension | Experimental | Other: CKD- sleep extensionMeasures as in baseline but with bed time increased by 2 hours |
| Controls short sleep | Experimental | Other: Controls Short sleepMeasures as in baseline but with sleep disruption |
Who may qualify
- Ages
- 21 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controls Short sleepAlso: Sleep interventionHealthy control subject's bedtime will be decreased by 2 hours/night with acoustic sleep disruption | Other | Controls short sleep |
| CKD- sleep extensionAlso: Sleep interventionSleep will be increased by 2 hours each night for 3 nights | Other | CKD- Sleep extension |
Primary outcome
Comparison of chronobiological profiles of renin/aldosterone, sympatho-vagal balance and CV function in CKD subjects to controls at baseline and after extended sleep in CKD subjects and after decreased time and quality of sleep in control subjects.
Time frame: Immediately after intervention.
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.
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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?
A study testing CKD- sleep extension in people with Chronic Kidney Disease, 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?
Comparison of chronobiological profiles of renin/aldosterone, sympatho-vagal balance and CV function in CKD subjects to controls at baseline and after extended sleep in CKD subjects and after decreased time and quality of sleep in control subjects. (time frame: Immediately after intervention.). 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.