Evaluation of a Portable Device for Assessing Sleep Disor... | NCT00493948

Studies
Evaluation of a Portable Device for Assessing Sleep Disordered Breathing in Congestive Heart Failure

NCT00493948

Sponsor

ResMed

Status

Completed

Last Update Posted

Nov 11, 2009Estimated

Enrollment

35Actual

Phase

Not provided

Conditions

Heart Failure, Congestive
Sleep Apnea Syndromes

Interventions

ApneaLink

Countries

Australia

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

Nov 2009

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

Jul 2007

Primary Completion Date

Apr 2009Actual

Completion Date

Apr 2009Actual

First Submitted Date

Jun 28, 2007

First Submission Date that Met QC Criteria

Jun 28, 2007

First Posted Date

Jun 29, 2007Estimated

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

Nov 9, 2009

Last Update Posted Date

Nov 11, 2009Estimated

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 evaluate an approved, portable device for assessing Sleep Disordered Breathing in Congestive Heart Failure.

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

35Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ApneaLink	Device	A two channel sleep screening device for the assessment of Sleep Disordered Breathing.

Measure	Description	Time Frame
Apnea- Hypopnea Index		Overnight

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Moderate to severe heart failure (as determined via Echocardiogram or treating physician)

Exclusion Criteria:

Clinically significant asthma requiring therapy
Significant (parenchymal) lung disease
Severe pulmonary hypertension
Hypercapnia (PCO2 > 60mmHg)
Cardiogenic Shock
Severe chronic renal failure
Narcotic abuse/intravenous drug use (including heart failure due to alcohol abuse or chemotherapy, HIV+ and Hepatitis C)
Methicillin- resistant Staphylococcus aureus infection
Tracheotomy
Enrolled in any concurrent study that may confound the results of this study
Nocturnal positive airway pressure or oxygen
Inability or refusal to sign patient consent form
Inability or refusal to adhere to protocol requirements

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

The study population under investigation are those people with moderate to severe heart failure who are currently admitted to the Coronary Care Unit of a major Sydney hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rachel A Coxon, BE/MBiomedE	ResMed/The University of New South Wales	Study Director
Klaus Schindhelm, PhD	ResMed/The University of New South Wales	Study Director
Jodie Lattimore, PhD	Royal Prince Alfred Hospital, Sydney, Australia	Study Director
Ian Wilcox, PhD	Royal Prince Alfred Hospital/The University of Sydney	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Prince Alfred Hospital		Camperdown	New South Wales	2050	Australia

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D012891	Sleep Apnea Syndromes

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001049	Apnea
D012120	Respiration Disorders

Browse Leaves

Not provided

Browse Branches

Not provided