Sleep Disturbances as a Non-traditional Risk Factor in CKD-Actigraphy

NCT ID: NCT00817674

Last Updated: 2013-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

353 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Kidney Disease Sleep Loss

Keywords

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CKD Kidney Disease poor sleep CKD progression

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

CKD subjects

No interventions assigned to this group

2

Healthy Controls

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Mild to Moderate CKD
* Healthy controls age and gender matched to CKD subjects
* Regular bedtimes of at least 6h/night, sedentary lifestyle

Exclusion Criteria

* Diabetes
* Current or previous dialysis for more than 1 month
* Uncontrolled hypertension
* Heart failure
* Liver disease
* HIV
* 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Illinois at Chicago

OTHER

Sponsor Role collaborator

Case Western Reserve University

OTHER

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eve Van Cauter, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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The University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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5R01DK071696

Identifier Type: NIH

Identifier Source: secondary_id

View Link

#14081A

Identifier Type: -

Identifier Source: org_study_id