Heart Failure, CongestiveNCT00493948
Evaluation of a Portable Device for Assessing Sleep Disordered Breathing in Congestive Heart Failure
An observational study of Heart Failure, Congestive and Sleep Apnea Syndromes, run by ResMed at 1 site in Australia.
Trial summary
The purpose of this study is to evaluate an approved, portable device for assessing Sleep Disordered Breathing in Congestive Heart Failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive, Sleep Apnea Syndromes
- What is being tested?
- ApneaLink
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2007to Apr 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- Moderate to severe heart failure (as determined via Echocardiogram or treating physician)
Who cannot join
- Clinically significant asthma requiring therapy
- Significant (parenchymal) lung disease
- Severe pulmonary hypertension
- Hypercapnia (PCO2 > 60mmHg)
- Cardiogenic Shock
- Severe chronic renal failure
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
About this study
The purpose of this study is to evaluate an approved, portable device for assessing Sleep Disordered Breathing in Congestive Heart Failure.
- Conditions
- Heart Failure, Congestive, Sleep Apnea Syndromes
- Being tested
- ApneaLink
- Medical subject headings
- Heart Failure, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApneaLinkDevice
A two channel sleep screening device for the assessment of Sleep Disordered Breathing.
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea- Hypopnea Index
Measured: Overnight
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- More trials run by ResMedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rachel A Coxon, BE/MBiomedE, Study director, ResMed/The University of New South WalesKlaus Schindhelm, PhD, Study director, ResMed/The University of New South WalesJodie Lattimore, PhD, Study director, Royal Prince Alfred Hospital, Sydney, AustraliaIan Wilcox, PhD, Principal investigator, Royal Prince Alfred Hospital/The University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493948
- Sponsor's protocol ID
- X06- 0237
- Status last verified
- Nov 2009
- First submitted
- 28 Jun 2007
- Last updated
- 11 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Portable Device for Assessing Sleep Disordered Breathing in Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT00493948
- Acronym / sponsor ID
- X06- 0237
- Conditions
- Heart Failure, Congestive, Sleep Apnea Syndromes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 29 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate an approved, portable device for assessing Sleep Disordered Breathing in Congestive Heart Failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (1 listed)
- Moderate to severe heart failure (as determined via Echocardiogram or treating physician)
Key exclusion criteria (13 listed)
- Clinically significant asthma requiring therapy
- Significant (parenchymal) lung disease
- Severe pulmonary hypertension
- Hypercapnia (PCO2 > 60mmHg)
- Cardiogenic Shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApneaLinkA two channel sleep screening device for the assessment of Sleep Disordered Breathing. | Device | – |
Primary outcome
Apnea- Hypopnea Index
Time frame: Overnight
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel A Coxon, BE/MBiomedE study director
ResMed/The University of New South Wales
Klaus Schindhelm, PhD study director
ResMed/The University of New South Wales
Jodie Lattimore, PhD study director
Royal Prince Alfred Hospital, Sydney, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, Congestive and Sleep Apnea Syndromes, run by ResMed at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea- Hypopnea Index (time frame: Overnight). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2009.