Pre-operative Polysomnography Assessment of Cardiac Surgery Inpatients

NCT ID: NCT00922168

Last Updated: 2014-02-06

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

146 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-08-31

Brief Summary

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

Detailed Description

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Conditions

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Sleep Disordered Breathing Obstructive Sleep Apnea Central Sleep Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiac Surgeries: CABG, valve replacements

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role collaborator

Cleveland Medical Devices Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hani A Kayyali, MS

Role: PRINCIPAL_INVESTIGATOR

Cleveland Medical Devices Inc

Nancy Foldvary, DO

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Nancy Collop, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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R44NS042451

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pre-op PSG

Identifier Type: -

Identifier Source: org_study_id

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