Cardiac DiseaseNCT00543452
Effect of Oxygen on Core Temperature
A study testing Oxygen in people with Cardiac Disease and Cheyne-Stokes Respiration, run by Umeå University at 1 site in Sweden.
Trial summary
Study of the effect of oxygen on the frequency of central apnea, sleep and body temperature in patients with a cardiac disease Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Disease, Cheyne-Stokes Respiration
- What is being tested?
- Oxygen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2005to Sep 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cardiac disease and Cheyne-Stokes respiration and controls without Cheyne-Stokes respiration
Who cannot join
- Obstructive sleep apnea
Trial locations and contacts
1 site in 1 country.
About this study
Study of the effect of oxygen on the frequency of central apnea, sleep and body temperature in patients with a cardiac disease
- Conditions
- Cardiac Disease, Cheyne-Stokes Respiration
- Being tested
- Oxygen, Air from a placebo oxygen delivery
- Medical subject headings
- Heart Diseases, Cheyne-Stokes Respiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenOther
4 liters of oxygen a minute
Air from a placebo oxygen deliveryOther
4 liters a minute of air from a placebo device
| Study group | Role | What they receive |
|---|---|---|
| oxygen | Active comparator | 4 liters of oxygen a minute Receives: Other: Oxygen |
| air | Placebo comparator | 4 liters of room air Receives: Other: Air from a placebo oxygen delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core temperature
This is an experitmetal study. Subjects receive oxygen or placebo-air during one night in random order. Outcome measure, i.e.core temperatue is measured continuously during this night with ongoing treatment of oxygen or placebo-air
Measured: One day
Secondary outcomes (1)
Sleep stages, apnea-hypopnea index
This is an experitmetal study. Subjects receive oxygen or placebo-air during one night in random order. Outcome measure, i.e.the amount of differernt sleep stages, total sleep time and apnea-hypopnea index is measured during this night with ongoing treatment of oxygen or placebo-air
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2007 (estimated)
- Study startFeb 2005
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Heart Lung Foundation
- Investigators
- Karl A Franklin, MD, PhD, Principal investigator, Dept Respiratory Medicine, University Hospital, Umeå
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543452
- Sponsor's protocol ID
- 03-567
- Status last verified
- Mar 2011
- First submitted
- 12 Oct 2007
- Last updated
- 7 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oxygen on Core Temperature
- ClinicalTrials.gov ID
- NCT00543452
- Acronym / sponsor ID
- 03-567
- Conditions
- Cardiac Disease, Cheyne-Stokes Respiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Swedish Heart Lung Foundation
- Study start
- Feb 2005
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 15 Oct 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.
Study of the effect of oxygen on the frequency of central apnea, sleep and body temperature in patients with a cardiac disease
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxygen | Active comparator | Other: Oxygen4 liters of oxygen a minute |
| air | Placebo comparator | Other: Air from a placebo oxygen delivery4 liters of room air |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Cardiac disease and Cheyne-Stokes respiration and controls without Cheyne-Stokes respiration
Key exclusion criteria (1 listed)
- Obstructive sleep apnea
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 |
|---|---|---|
| Oxygen4 liters of oxygen a minute | Other | oxygen |
| Air from a placebo oxygen delivery4 liters a minute of air from a placebo device | Other | air |
Primary outcome
Core temperature
Time frame: One day
This is an experitmetal study. Subjects receive oxygen or placebo-air during one night in random order. Outcome measure, i.e.core temperatue is measured continuously during this night with ongoing treatment of oxygen or placebo-air
1 secondary outcome
Sleep stages, apnea-hypopnea index
Time frame: One day
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 7 Apr 2011.
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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 Oxygen in people with Cardiac Disease and Cheyne-Stokes Respiration, 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 1 inclusion and 1 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 7 Apr 2011. 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. Some participants in this study may receive a placebo. 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?
Core temperature (time frame: One day). 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 7 Apr 2011.