Prevalence of Sleep Disordered Breathing | NCT01011647

Studies
Prevalence of Sleep Disordered Breathing

NCT01011647

Sponsor

GE Healthcare

Status

Terminated

Last Update Posted

Jan 5, 2012Estimated

Enrollment

53Actual

Phase

Not provided

Conditions

Unstable Angina
Acute Myocardial Infarction
Congestive Heart Failure

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

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Inadequate recruitment

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Nov 10, 2009

First Submission Date that Met QC Criteria

Nov 10, 2009

First Posted Date

Nov 11, 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

Jan 4, 2012

Last Update Posted Date

Jan 5, 2012Estimated

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

A novel technique in identifying unspecified sleep apnea has been developed. This technique uses signals typical acquired from a bedside monitor that is found in critical care environments. Those signals are then processed by a sleep analysis algorithm to provide an Apnoea Hypopnea Index (AHI) score. This study is intended to determine whether the prevalence of sleep disordered breathing identification among patients in a Coronary Care Unit (CCU) using this novel approach is significantly different than using routine techniques.

Detailed Description

This study will focus on inpatients diagnosed with coronary conditions. Specific eligibility criteria will include:

Unstable angina
Acute myocardial infarction
Congestive heart failure Subjects enrolled in the study will be scored for sleep apnea using a novel approach designed by the sponsor. That score will not be used in the course of treatment. A follow-up call will determine whether the subject was identified for sleep disordered breathing during the hospital stay. A comparison will be done on the number of those identified with and without the use of the sleep scoring device.

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

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acute coronary conditions		Patients hospitalized with the following conditions Unstable angina Acute myocardial infarction Congestive heart failure

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sleep disordered breathing was detected either by signals obtained from patient monitoring or by standard approaches by the site.		3 months

Secondary Outcomes

Measure	Description	Time Frame
Length of CCU stay		3 months
Length of hospital stay		3 months
Prevalence of various sleep variables and correlation to known clinical and laboratory prognostic parameters

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age equal to or greater than 18 years at time of consent
Written informed consent
Patients admitted to the intensive care unit if able to remove oxygen
Patients admitted to telemetry and step-down floor that will not require oxygen
Primary diagnosis (any of the following)
Un-stable angina
Acute myocardial infarction
Congestive heart failure

Exclusion Criteria:

Previously diagnosed sleep disordered breathing
Inability to consent
Pregnancy
Intubation (no longer excluded after extubation)
Oxygen therapy (no longer excluded after therapy ends)
End-Stage renal disease
End-Stage liver disease
Terminal disorders other than cardiac
Severe scoliosis
Cervical spinal cord injuries
Neuromuscular disorders
Severe COPD as defined by prescription of home oxygen therapy
Other unsuitable circumstances

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subject selection will come from patients admitted to the hospital with an acute cornonary condition.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ohio State University Medical Center		Columbus	Ohio	43210	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
180875	Background	Guilleminault C, Tilkian A, Dement WC. The sleep apnea syndromes. Annu Rev Med. 1976;27:465-84. doi: 10.1146/annurev.me.27.020176.002341. No abstract available.
216912	Background	Block AJ, Boysen PG, Wynne JW, Hunt LA. Sleep apnea, hypopnea and oxygen desaturation in normal subjects. A strong male predominance. N Engl J Med. 1979 Mar 8;300(10):513-7. doi: 10.1056/NEJM197903083001001.

ID	Term
D000787	Angina Pectoris
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D000789	Angina, Unstable
D006333	Heart Failure