Sleep Apnea SyndromesNCT00570115
Left Atrial Volume and Function Evaluation in Patients With Obstructive Sleep Apnea
An observational study of Sleep Apnea Syndromes, 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 atrial morphology and function evaluated by echocardiography three dimensional Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea Syndromes
- How many people
- 106 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2007to Nov 2007
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigators recruited 56 recently diagnosed OSA patients, confirmed by full polysomnography (PSG), referred to Sleep Laboratory of Psychobiology Department of Federal University of Sao Paulo, Brazil, according to the following inclusion criteria: both genders aging from 29 to 70 years old, with apnea-hypopnea index (AHI) >5 events/hour of sleep. Control group comprised 50 healthy community subjects without OSA confirmed by full PSG, matched by age, gender, and BMI.
Who may be able to join
- Age from 30 to 70
- Apnea-hypopnea index > 5 by polysomnography
Who cannot join
- Any cardiac disease
- Poor imaging quality by mean of echocardiography
- non-sinusal Rhythm
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Sono/Federal University of Sao Paulo
São Paulo, São Paulo, 04020060
About this study
Official title: Left Atrial Volume and Function in Patients With Obstructive Sleep Apnea Assessed by Real Time Three Dimensional Echocardiography
The purpose of this study is to determine whether patients with obstructive sleep apnea have any changes in left atrial morphology and function evaluated by echocardiography three dimensional
Read the detailed description
Several studies have been suggesting that Obstructive Sleep Apnea contributes to deterioration of left ventricular diastolic function . It may lead to atrial myocardium stretching and enlargement which may be associated to increased risk of cardiovascular events. We hypothesized that morphological and functional LA changes might be found using three dimensional echo, and that such alterations are related to obstructive sleep apnea presence.
- Conditions
- Sleep Apnea Syndromes
- Keywords
- Sleep Apnea Syndromes diastolic disfunction left atrium
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | The subjects for this group are matched for age, gender, body mass index. The presence of obstructive sleep apnea will divide the cohort in 02 subgroups: non-Obstructive Sleep Apnea and Obstructive Sleep Apnea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Atrial enlargement
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2007 (estimated)
- Study startJun 2007
- Study completionNov 2007
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 Sleep Apnea SyndromesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associação Fundo de Incentivo à Pesquisa
- Sponsor type
- University, hospital or other
- Investigators
- Sergio Tufik, PhD,MD., Study director, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570115
- Sponsor's protocol ID
- ecoera-001
- Status last verified
- Dec 2007
- First submitted
- 7 Dec 2007
- Last updated
- 8 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Anwar AM, Soliman OI, Geleijnse ML, Nemes A, Vletter WB, ten Cate FJ. Assessment of left atrial volume and function by real-time three-dimensional echocardiography. Int J Cardiol. 2008 Jan 11;123(2):155-61. doi: 10.1016/j.ijcard.2006.12.017. Epub 2007 Apr 17.
PubMed 17442422
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
- Left Atrial Volume and Function in Patients With Obstructive Sleep Apnea Assessed by Real Time Three Dimensional Echocardiography
- ClinicalTrials.gov ID
- NCT00570115
- Acronym / sponsor ID
- ecoera-001
- Conditions
- Sleep Apnea Syndromes
- Keywords
- Sleep Apnea Syndromes diastolic disfunction left atrium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Associação Fundo de Incentivo à PesquisaUniversity, hospital or other
- Study start
- Jun 2007
- Study completion
- Nov 2007 (actual)
- First posted
- 10 Dec 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 determine whether patients with obstructive sleep apnea have any changes in left atrial morphology and function evaluated by echocardiography three dimensional
Detailed description
Several studies have been suggesting that Obstructive Sleep Apnea contributes to deterioration of left ventricular diastolic function . It may lead to atrial myocardium stretching and enlargement which may be associated to increased risk of cardiovascular events. We hypothesized that morphological and functional LA changes might be found using three dimensional echo, and that such alterations are related to obstructive sleep apnea presence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | –The subjects for this group are matched for age, gender, body mass index. The presence of obstructive sleep apnea will divide the cohort in 02 subgroups: non-Obstructive Sleep Apnea and Obstructive Sleep Apnea |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators recruited 56 recently diagnosed OSA patients, confirmed by full polysomnography (PSG), referred to Sleep Laboratory of Psychobiology Department of Federal University of Sao Paulo, Brazil, according to the following inclusion criteria: both genders aging from 29 to 70 years old, with apnea-hypopnea index (AHI) >5 events/hour of sleep. Control group comprised 50 healthy community subjects without OSA confirmed by full PSG, matched by age, gender, and BMI.
Key inclusion criteria (2 listed)
- Age from 30 to 70
- Apnea-hypopnea index > 5 by polysomnography
Key exclusion criteria (3 listed)
- Any cardiac disease
- Poor imaging quality by mean of echocardiography
- non-sinusal Rhythm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Left Atrial enlargement
Time frame: 1 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 8 May 2012.
- Background: PubMed 17442422Anwar AM, Soliman OI, Geleijnse ML, Nemes A, Vletter WB, ten Cate FJ. Assessment of left atrial volume and function by real-time three-dimensional echocardiography. Int J Cardiol. 2008 Jan 11;123(2):155-61. doi: 10.1016/j.ijcard.2006.12.017. Epub 2007 Apr 17.
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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.
Sergio Tufik, PhD,MD. study director
Federal University of São Paulo
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 Sleep Apnea Syndromes, 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 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 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. 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?
Left Atrial enlargement (time frame: 1 day). 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 NCT00570115, 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.