Obstructive Sleep ApneaNCT00768807
Structural and Functional Left Ventricular Remodelling in Patients With Obstructive Sleep Apnea
A study testing CPAP (continuous positive airway pressure) in people with Obstructive Sleep Apnea, run by Associação Fundo de Incentivo à Pesquisa at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether patients with obstructive sleep apnea have any changes in left ventricular function and structure after 06 months of continuous positive airway pressure treatment. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- CPAP (continuous positive airway pressure)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2009to 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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apnea-hypopnea index higher than 5 events per hour
Who cannot join
- Body mass index higher than 40 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether patients with obstructive sleep apnea have any changes in left ventricular function and structure after 06 months of continuous positive airway pressure treatment.
Read the detailed description
Several studies have been suggesting that Obstructive Sleep Apnea contributes to deterioration of left ventricular diastolic function. It may be associated to increased risk of cardiovascular events. We hypothesized that morphological and functional left ventricular changes might be reverted after treatment with Continuous positive airway pressure.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- CPAP (continuous positive airway pressure)
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP (continuous positive airway pressure)Device
Patients treated by CPAP for 06 months
| Study group | Role | What they receive |
|---|---|---|
| Sham CPAP | Sham comparator | Patients submitted to SHAM CPAP use for 06 months Receives: Device: CPAP (continuous positive airway pressure) |
| CPAP | Active comparator | OSA patients submitted to 06 months of CPAP treatment Receives: Device: CPAP (continuous positive airway pressure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of left ventricular diastolic echo variable
Measured: 06 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startOct 2009
- Primary completionOct 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associação Fundo de Incentivo à Pesquisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wercules Antonio Alves de Oliveira, Associação Fundo de Incentivo à Pesquisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768807
- Sponsor's protocol ID
- ECOera-03
- Status last verified
- May 2012
- First submitted
- 6 Oct 2008
- Last updated
- 8 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Oliveira W, Campos O, Cintra F, Matos L, Vieira ML, Rollim B, Fujita L, Tufik S, Poyares D. Impact of continuous positive airway pressure treatment on left atrial volume and function in patients with obstructive sleep apnoea assessed by real-time three-dimensional echocardiography. Heart. 2009 Nov;95(22):1872-8. doi: 10.1136/hrt.2009.173625. Epub 2009 Jul 29.
PubMed 19643769
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural and Functional Left Ventricular Remodelling in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00768807
- Acronym / sponsor ID
- ECOera-03
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Associação Fundo de Incentivo à PesquisaUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 8 Oct 2008 (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 patients with obstructive sleep apnea have any changes in left ventricular function and structure after 06 months of continuous positive airway pressure treatment.
Detailed description
Several studies have been suggesting that Obstructive Sleep Apnea contributes to deterioration of left ventricular diastolic function. It may be associated to increased risk of cardiovascular events. We hypothesized that morphological and functional left ventricular changes might be reverted after treatment with Continuous positive airway pressure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham CPAP | Sham comparator | Device: CPAP (continuous positive airway pressure)Patients submitted to SHAM CPAP use for 06 months |
| CPAP | Active comparator | Device: CPAP (continuous positive airway pressure)OSA patients submitted to 06 months of CPAP treatment |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Apnea-hypopnea index higher than 5 events per hour
Key exclusion criteria (1 listed)
- Body mass index higher than 40 kg/m2
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 |
|---|---|---|
| CPAP (continuous positive airway pressure)Patients treated by CPAP for 06 months | Device | CPAP, Sham CPAP |
Primary outcome
Improvement of left ventricular diastolic echo variable
Time frame: 06 months
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 8 May 2012.
- Derived from this study: PubMed 19643769Oliveira W, Campos O, Cintra F, Matos L, Vieira ML, Rollim B, Fujita L, Tufik S, Poyares D. Impact of continuous positive airway pressure treatment on left atrial volume and function in patients with obstructive sleep apnoea assessed by real-time three-dimensional echocardiography. Heart. 2009 Nov;95(22):1872-8. doi: 10.1136/hrt.2009.173625. Epub 2009 Jul 29.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP (continuous positive airway pressure) in people with Obstructive Sleep Apnea, run by Associação Fundo de Incentivo à Pesquisa at 1 site in Brazil.
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 8 May 2012. 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 Brazil. 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?
Improvement of left ventricular diastolic echo variable (time frame: 06 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00768807, which also lists 1 linked publication.
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 8 May 2012.