NCT00817492

Brief Summary

This study will help determine the relationship between impaired sleep and chronic kidney disease, specifically to determine if sleep disturbances are a risk factor for worsening kidney function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

4.9 years

First QC Date

January 5, 2009

Last Update Submit

September 4, 2013

Conditions

Chronic Kidney Disease

Keywords

SleepCKDkidneyPSGpolysomnographyDecreased sleep timeDecreased sleep quality

Outcome Measures

Primary Outcomes (1)

  • Sleep Quality

    Sleep Quality was determined after PSG on all subjects were completed

Study Arms (2)

1

Subjects with mild to moderate kidney disease

2

Healthy Control Subjects

Eligibility Criteria

Age21 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Renal Clinic patients at The University of Illinois at Chicago Hospital

You may qualify if:

  • CKD subjects will be participants in a larger study, CRIC, at the University of Illinois, Chicago
  • Healthy controls age and gender matched to 30 CKD subjects, regular bedtimes of at least 6h/night, sedentary lifestyle

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Illinois at Chicago

Chicago, Illinois, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eve Van Cauter, PhD

    University of Chicago

    PRINCIPAL INVESTIGATOR

  • James Lash, MD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2009

First Posted

January 6, 2009

Study Start

July 1, 2006

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

September 5, 2013

Record last verified: 2013-09

Locations

US(1)