NCT00922168

Brief Summary

The purpose of this study is to assess the prevalence and morbidity rates of sleep disordered breathing in cardiac surgery patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2007

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

March 1, 2007

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

February 6, 2014

Status Verified

February 1, 2014

Enrollment Period

3.4 years

First QC Date

June 15, 2009

Last Update Submit

February 5, 2014

Conditions

Sleep Disordered BreathingObstructive Sleep ApneaCentral Sleep Apnea

Keywords

Sleepapneaobstructivecentral

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Sleep Disordered Breathing in Cardiac Surgery Patients

    September 2009

Secondary Outcomes (1)

  • Assess Post-Operative Complications of Patients with Sleep Disordered Breathing

    September 2009

Study Arms (1)

Cardiac Surgeries: CABG, valve replacements

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

cardiac surgery patients

You may qualify if:

  • Subjects undergoing major cardiovascular surgery (coronary artery bypass graft, valve replacement surgery, or aortic surgery) under general anesthesia.
  • Subjects in whom surgery is planned for greater than 1 day but less than 60 days from the time of enrollment.

You may not qualify if:

  • Subjects treated for sleep apnea with positive airway pressure (PAP) therapy or oral appliance in the past 30 days.
  • Subjects undergoing Maze procedure for atrial fibrillation.
  • Subjects unable to comply with study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesSleep Apnea, ObstructiveSleep Apnea, CentralApnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hani A Kayyali, MS

    Cleveland Medical Devices Inc

    PRINCIPAL INVESTIGATOR

  • Nancy Foldvary, DO

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

  • Nancy Collop, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2009

First Posted

June 17, 2009

Study Start

March 1, 2007

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

February 6, 2014

Record last verified: 2014-02

Locations

US(2)