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

Heart Failure, Congestive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00493948
• Other study ID #: X06- 0237
• Status: Completed
• Phase: N/A
• First received: June 28, 2007
• Last updated: November 9, 2009
• Start date: July 2007
• Est. completion date: April 2009

Study information

• Verified date: November 2009
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive
• Sleep Apnea Syndromes

Intervention

Device:
• ApneaLink
A two channel sleep screening device for the assessment of Sleep Disordered Breathing.

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea- Hypopnea Index		Overnight	No