NCT00493948

Brief Summary

The purpose of this study is to evaluate an approved, portable device for assessing Sleep Disordered Breathing in Congestive Heart Failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

June 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2007

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

November 11, 2009

Status Verified

November 1, 2009

Enrollment Period

1.8 years

First QC Date

June 28, 2007

Last Update Submit

November 9, 2009

Conditions

Heart Failure, CongestiveSleep Apnea Syndromes

Outcome Measures

Primary Outcomes (1)

  • Apnea- Hypopnea Index

    Overnight

Interventions

ApneaLinkDEVICE

A two channel sleep screening device for the assessment of Sleep Disordered Breathing.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

MeSH Terms

Conditions

Heart FailureSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • 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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 28, 2007

First Posted

June 29, 2007

Study Start

July 1, 2007

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

November 11, 2009

Record last verified: 2009-11

Locations

AU(1)