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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00493948




Registration number
NCT00493948
Ethics application status
Date submitted
28/06/2007
Date registered
29/06/2007
Date last updated
11/11/2009

Titles & IDs
Public title
Evaluation of a Portable Device for Assessing Sleep Disordered Breathing in Congestive Heart Failure
Scientific title
Evaluation of a Portable Device for Assessing Sleep Disordered Breathing in Congestive Heart Failure
Secondary ID [1] 0 0
X06- 0237
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure, Congestive 0 0
Sleep Apnea Syndromes 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - ApneaLink

Treatment: Devices: ApneaLink
A two channel sleep screening device for the assessment of Sleep Disordered Breathing.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Apnea- Hypopnea Index
Timepoint [1] 0 0
Overnight

Eligibility
Key inclusion criteria
- Moderate to severe heart failure (as determined via Echocardiogram or treating
physician)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2009
Sample size
Target
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 0 0
2050 - Camperdown

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ResMed
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate an approved, portable device for assessing Sleep
Disordered Breathing in Congestive Heart Failure.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00493948
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rachel A Coxon, BE/MBiomedE
Address 0 0
ResMed/The University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries