Sleep Disturbances as a Risk Factor in Chronic Kidney Disease

NCT ID: NCT00817427

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

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Kidney Disease

Keywords

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Chronic Kidney Disease Poor sleep CKD Kidney Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Baseline

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

Group Type NO_INTERVENTION

No interventions assigned to this group

CKD- Sleep extension

Measures as in baseline but with bed time increased by 2 hours

Group Type EXPERIMENTAL

CKD- sleep extension

Intervention Type OTHER

Sleep will be increased by 2 hours each night for 3 nights

Controls short sleep

Measures as in baseline but with sleep disruption

Group Type EXPERIMENTAL

Controls Short sleep

Intervention Type OTHER

Healthy control subject's bedtime will be decreased by 2 hours/night with acoustic sleep disruption

Interventions

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Controls Short sleep

Healthy control subject's bedtime will be decreased by 2 hours/night with acoustic sleep disruption

Intervention Type OTHER

CKD- sleep extension

Sleep will be increased by 2 hours each night for 3 nights

Intervention Type OTHER

Other Intervention Names

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Sleep intervention Sleep intervention

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 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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5RO1DK71696-4

Identifier Type: -

Identifier Source: secondary_id

5R01DK071696

Identifier Type: NIH

Identifier Source: secondary_id

View Link

#14075A

Identifier Type: -

Identifier Source: org_study_id