Pre-operative Polysomnography Assessment of Cardiac Surge... | NCT00922168

Studies
Pre-operative Polysomnography Assessment of Cardiac Surgery Inpatients

NCT00922168

Sponsor

Cleveland Medical Devices Inc

Status

Completed

Last Update Posted

Feb 6, 2014Estimated

Enrollment

146Actual

Phase

Not provided

Conditions

Sleep Disordered Breathing
Obstructive Sleep Apnea
Central Sleep Apnea

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R44NS042451	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Aug 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Jun 15, 2009

First Submission Date that Met QC Criteria

Jun 16, 2009

First Posted Date

Jun 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2014

Last Update Posted Date

Feb 6, 2014Estimated

Name	Class
National Institutes of Health (NIH)	NIH
The Cleveland Clinic	OTHER
Johns Hopkins University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

146Actual

Label	Type	Description	Intervention Names
Cardiac Surgeries: CABG, valve replacements

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of Sleep Disordered Breathing in Cardiac Surgery Patients		September 2009

Secondary Outcomes

Measure	Description	Time Frame
Assess Post-Operative Complications of Patients with Sleep Disordered Breathing		September 2009

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

cardiac surgery patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins University		Baltimore	Maryland	21205	United States
Cleveland Clinic Foundation

Condition Browse Module

MeSH Terms

ID	Term
D012891	Sleep Apnea Syndromes
D020181	Sleep Apnea, Obstructive
D020182	Sleep Apnea, Central
D001049	Apnea

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias

Browse Leaves

Not provided

Browse Branches

Not provided