Obstructive Sleep ApneaERANCT00768625
Cardiovascular Risk Stratification in Patients With Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea and Obesity, run by Associacao Fundo de Incentivo a Psicofarmcologia at 1 site in Brazil.
Trial summary
The purpose of this study is: 1. To determine the frequency of cardiovascular diseases in patients with OSA, obese, overweight, and lean (BMI<25) 2. To analyze the CPAP treatment over the clinical evolution of OSA patients 3. To determine if OSA is a independent predictor of cardiovascular risk Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Obesity
- How many people
- 2,000 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2005to Dec 2012
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1000 OSA patients and 1000 controls enrolled from Instituto do Sono database 500 subjects with body mass index less than 25
Who may be able to join
- Men and women with OSA (apnea-hypopnea index higher than 5 events/hour)
Who cannot join
- Body mass index higher than 40
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Sono/AFIP
São Paulo, São Paulo, 04516001
Fatima D Cintra, MD, PhD, 55 11 99698555, fatimacintra@interair.com.br
Wercules Oliveira, 55 11 50551272, wercules1@hotmail.com
About this study
The purpose of this study is:
- To determine the frequency of cardiovascular diseases in patients with OSA, obese, overweight, and lean (BMI<25)
- To analyze the CPAP treatment over the clinical evolution of OSA patients
- To determine if OSA is a independent predictor of cardiovascular risk
Read the detailed description
Obstructive Sleep Apnea (OSA) is a condition with important cardiovascular repercussions. However, the association between OSA, cardiovascular diseases, and obesity has not been totally clarified. We hypothesized that the cardiovascular consequences of OSA are due to obesity.
- Conditions
- Obstructive Sleep Apnea, Obesity
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular events
Measured: five years
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 startApr 2005
- Primary completionMar 2011 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associacao Fundo de Incentivo a Psicofarmcologia
- Sponsor type
- University, hospital or other
- Investigators
- Fatima D Cintra, PhD, Principal investigator, Associacao Fundo de Incentivo a PsicofarmcologiaDalva Poyares, PhD, Study chair, Associacao Fundo de Incentivo a PsicofarmcologiaSergio Tufik, PhD, Study director, Associacao Fundo de Incentivo a Psicofarmcologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768625
- Sponsor's protocol ID
- ERA
- Acronym
- ERA
- Status last verified
- Oct 2008
- First submitted
- 7 Oct 2008
- Last updated
- 8 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Feres MC, Fonseca FA, Cintra FD, Mello-Fujita L, de Souza AL, De Martino MC, Tufik S, Poyares D. An assessment of oxidized LDL in the lipid profiles of patients with obstructive sleep apnea and its association with both hypertension and dyslipidemia, and the impact of treatment with CPAP. Atherosclerosis. 2015 Aug;241(2):342-9. doi: 10.1016/j.atherosclerosis.2015.05.008. Epub 2015 May 23.
PubMed 26071656Cintra FD, Tufik S, Paola Ad, Feres MC, Melo-Fujita L, Oliveira W, Rizzi C, Poyares D. Cardiovascular profile in patients with obstructive sleep apnea. Arq Bras Cardiol. 2011 Apr;96(4):293-9. doi: 10.1590/s0066-782x2011005000030. Epub 2011 Mar 18. English, Portuguese, Spanish.
PubMed 21437515Rizzi CF, Cintra F, Risso T, Pulz C, Tufik S, de Paola A, Poyares D. Exercise capacity and obstructive sleep apnea in lean subjects. Chest. 2010 Jan;137(1):109-14. doi: 10.1378/chest.09-1201. Epub 2009 Oct 3.
PubMed 19801583
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk Stratification in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00768625
- Acronym / sponsor ID
- ERA / ERA
- Conditions
- Obstructive Sleep Apnea, Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Associacao Fundo de Incentivo a PsicofarmcologiaUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Dec 2012 (estimated)
- 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 the frequency of cardiovascular diseases in patients with OSA, obese, overweight, and lean (BMI<25)
- To analyze the CPAP treatment over the clinical evolution of OSA patients
- To determine if OSA is a independent predictor of cardiovascular risk
Detailed description
Obstructive Sleep Apnea (OSA) is a condition with important cardiovascular repercussions. However, the association between OSA, cardiovascular diseases, and obesity has not been totally clarified. We hypothesized that the cardiovascular consequences of OSA are due to obesity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1000 OSA patients and 1000 controls enrolled from Instituto do Sono database 500 subjects with body mass index less than 25
Key inclusion criteria (1 listed)
- Men and women with OSA (apnea-hypopnea index higher than 5 events/hour)
Key exclusion criteria (1 listed)
- Body mass index higher than 40
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
Cardiovascular events
Time frame: five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2008.
- Derived from this study: PubMed 26071656Feres MC, Fonseca FA, Cintra FD, Mello-Fujita L, de Souza AL, De Martino MC, Tufik S, Poyares D. An assessment of oxidized LDL in the lipid profiles of patients with obstructive sleep apnea and its association with both hypertension and dyslipidemia, and the impact of treatment with CPAP. Atherosclerosis. 2015 Aug;241(2):342-9. doi: 10.1016/j.atherosclerosis.2015.05.008. Epub 2015 May 23.
- Derived from this study: PubMed 21437515Cintra FD, Tufik S, Paola Ad, Feres MC, Melo-Fujita L, Oliveira W, Rizzi C, Poyares D. Cardiovascular profile in patients with obstructive sleep apnea. Arq Bras Cardiol. 2011 Apr;96(4):293-9. doi: 10.1590/s0066-782x2011005000030. Epub 2011 Mar 18. English, Portuguese, Spanish.
- Derived from this study: PubMed 19801583Rizzi CF, Cintra F, Risso T, Pulz C, Tufik S, de Paola A, Poyares D. Exercise capacity and obstructive sleep apnea in lean subjects. Chest. 2010 Jan;137(1):109-14. doi: 10.1378/chest.09-1201. Epub 2009 Oct 3.
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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.
Fatima D Cintra, PhD principal investigator
Associacao Fundo de Incentivo a Psicofarmcologia
Dalva Poyares, PhD study chair
Associacao Fundo de Incentivo a Psicofarmcologia
Sergio Tufik, PhD study director
Associacao Fundo de Incentivo a Psicofarmcologia
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 Obstructive Sleep Apnea and Obesity, run by Associacao Fundo de Incentivo a Psicofarmcologia 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: status not confirmed, as of the sponsor's last update on 8 Oct 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatima D Cintra, MD, PhD (55 11 99698555, fatimacintra@interair.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular events (time frame: five years). 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 NCT00768625, which also lists 3 linked publications.
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 Oct 2008; AzTrials last refreshed its copy on 6 Nov 2026.