Heart FailureNCT00338078
Nocturnal Oxygen Treatment in Heart Failure and Cheyne-Stokes Respiration
A study testing nocturnal oxygen treatment from oxygen concentrators in people with Heart Failure, run by Umeå University at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether oxygen therapy during sleep improves quality of life, exercise capacity and heart function among patients with chronic heart failure and central sleep apnea. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- nocturnal oxygen treatment from oxygen concentrators
- Type of treatment
- Medical device
- How many people
- 62 participants
- Where
- 1 siteSweden
- Study dates
- Mar 1999to Dec 2006
- Phase
- Interventional
- 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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable heart failure with left ventricular dysfunction
- Cheyne-Stokes respiration with central AHI>15 and obstructive AHI<5
Who cannot join
- Heart infarction within 3 months.
- Dementia
- Chronic obstructive pulmonary disease and daytime hypoxemia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nocturnal Oxygen Treatment in Heart Failure and Cheyne-Stokes Respiration. A Randomized Double-Blind Placebo Controlled Cross-Over Study
The purpose of this study is to determine whether oxygen therapy during sleep improves quality of life, exercise capacity and heart function among patients with chronic heart failure and central sleep apnea.
Read the detailed description
Oxygen therapy reduces the number of central apneas among patients with congestive heart failure but it is unknown whether quality of life and heart function also improve. We aim to test whether the quality of life, exercise capacity and heart function are improved with nocturnal oxygen therapy during 6 weeks with nocturnal oxygen from oxygen concentrator or nocturnal air from placebo concentrator.
- Conditions
- Heart Failure
- Being tested
- nocturnal oxygen treatment from oxygen concentrators
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nocturnal oxygen treatment from oxygen concentratorsDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity
Quality of life (SF-36, Minnesota, Living with heart failure questionnaire)
Brain natriuretic peptide (BNP)
Secondary outcomes (12)
Echocardiography
Radionuclide determination of ejection fraction
Mortality and hospitalization for cardiovascular causes (combined and individually)
Hospitality anxiety and depression scale
Epworth sleepiness scale
Karolinska sleepiness scale
Routine lab (haemoglobins, thyroid status, creatinin)
Urinary catecholamines
Urinary cortisol
Polysomnography
Arrhythmias from 24 hour Holter-ECG registration
Heart rate variability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startMar 1999
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Investigators
- Karl A Franklin, MD, PhD, Principal investigator, Dept Respiratory Medicine, University Hospital, Umeå
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338078
- Sponsor's protocol ID
- 241/98, dnr 98-165
- Status last verified
- Jun 2008
- First submitted
- 16 Jun 2006
- Last updated
- 2 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nocturnal Oxygen Treatment in Heart Failure and Cheyne-Stokes Respiration. A Randomized Double-Blind Placebo Controlled Cross-Over Study
- ClinicalTrials.gov ID
- NCT00338078
- Acronym / sponsor ID
- 241/98, dnr 98-165
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Mar 1999
- Study completion
- Dec 2006 (actual)
- First posted
- 20 Jun 2006 (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 determine whether oxygen therapy during sleep improves quality of life, exercise capacity and heart function among patients with chronic heart failure and central sleep apnea.
Detailed description
Oxygen therapy reduces the number of central apneas among patients with congestive heart failure but it is unknown whether quality of life and heart function also improve. We aim to test whether the quality of life, exercise capacity and heart function are improved with nocturnal oxygen therapy during 6 weeks with nocturnal oxygen from oxygen concentrator or nocturnal air from placebo concentrator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stable heart failure with left ventricular dysfunction
- Cheyne-Stokes respiration with central AHI>15 and obstructive AHI<5
Key exclusion criteria (3 listed)
- Heart infarction within 3 months.
- Dementia
- Chronic obstructive pulmonary disease and daytime hypoxemia.
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 |
|---|---|---|
| nocturnal oxygen treatment from oxygen concentrators | Device | – |
Primary outcome
Exercise capacity
Quality of life (SF-36, Minnesota, Living with heart failure questionnaire)
Brain natriuretic peptide (BNP)
12 secondary outcomes
Echocardiography
Radionuclide determination of ejection fraction
Mortality and hospitalization for cardiovascular causes (combined and individually)
Hospitality anxiety and depression scale
Epworth sleepiness scale
Karolinska sleepiness scale
Routine lab (haemoglobins, thyroid status, creatinin)
Urinary catecholamines
Urinary cortisol
Polysomnography
Arrhythmias from 24 hour Holter-ECG registration
Heart rate variability
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 2 Jul 2008.
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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.
Karl A Franklin, MD, PhD principal investigator
Dept Respiratory Medicine, University Hospital, Umeå
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nocturnal oxygen treatment from oxygen concentrators in people with Heart Failure, run by Umeå University at 1 site in Sweden.
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 2 inclusion and 3 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 2 Jul 2008. 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 Sweden. 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?
Exercise capacity. The study lists 3 primary outcomes in all. 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 2 Jul 2008.