Obstructive Sleep ApneaPhase 4NCT00400543
Early Signs of Atherosclerosis in Obstructive Sleep Apnea: Effects of Treatment
A Phase 4 study testing Continuous positive airway pressure (CPAP) in people with Obstructive Sleep Apnea and Atherosclerosis, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Obstructive sleep apnea (OSA) is associated with adverse cardiovascular outcomes, including acute myocardial infarction and stroke. Atherosclerosis is an important step for these events. Recent studies demonstrated the independent association between OSA and validated markers of atherosclerosis. Read more about this study
- Who is it for?
- Ages 30 to 60 years, men only
- Conditions the study is for
- Obstructive Sleep Apnea, Atherosclerosis
- What is being tested?
- Continuous positive airway pressure (CPAP)
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2004to Jul 2006
- Phase
- Phase 4
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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Males with recent sleep study (<1 month) showing severe obstructive sleep apnea, defined as at least 30 events of apnea and hypopnea per hour of sleep.
Who cannot join
- Age >60 years old, body mass index (BMI) >35 kg/m2, diabetes mellitus, hypertension, cerebrovascular, aortic, heart, and valvar heart diseases, renal failure, arrhythmias, smoking habit, and chronic use of medications, including statins.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute (InCor) - University of São Paulo Medical School
São Paulo, São Paulo, 05403-904
About this study
Official title: Effects of Continuous Positive Airway Pressure (CPAP) on Early Signs of Atherosclerosis in Patients With Obstructive Sleep Apnea: a Randomized Study
Obstructive sleep apnea (OSA) is associated with adverse cardiovascular outcomes, including acute myocardial infarction and stroke. Atherosclerosis is an important step for these events. Recent studies demonstrated the independent association between OSA and validated markers of atherosclerosis. However, the impact of treatment with continuous positive airway pressure (CPAP) on these markers is unknown.
The purpose of this study is to determine whether CPAP therapy can reverses early signs of atherosclerosis in apparently healthy OSA patients.
Read the detailed description
Obstructive sleep apnea (OSA) is characterized by recurrent episodes of partial or complete obstruction of the upper airway during sleep resulting in oxygen desaturation and arousals from sleep. OSA is recognized as an important public health problem, affecting 9 and 24 % of middle-aged females and males, respectively. There is now compelling evidence that severe OSA is associated with increased cardiovascular morbidity and mortality, mainly due to acute myocardial infarction and stroke. Moreover, the current standard treatment with application of continuous positive airway pressure (CPAP) during the night was associated with decreased non-fatal and fatal cardiovascular events.
There are several mechanisms associated with OSA that are potentially harmful to the cardiovascular system, including sympathetic activation, systemic inflammation, production of reactive oxygen species, and endothelial dysfunction. Together, all these factors could contribute to atherosclerosis progression, a key mechanism involved in the genesis of myocardial infarction and stroke. For instance, we recently described the presence of early signs of atherosclerosis in otherwise healthy OSA subjects as characterized by alterations in validated markers of atherosclerosis, including increased arterial stiffness, evaluated by pulse wave velocity (PWV), as well as intima-media thickness (IMT) and carotid diameter (CD). All theses vascular abnormalities correlated significantly with the severity of the OSA.
In this study, we will perform a randomized study to evaluate the impact of CPAP therapy on PWV, IMT and CD as well as in catecholamine and C reactive protein. We made the hypothesis that CPAP promotes beneficial effects on atherosclerosis, independent of the other factors, such as blood pressure and cholesterol levels. To this end, we only will study young OSA patients that were free of co-morbidities. Patients will be randomized to no treatment (Control) or CPAP for 4 months. Evalutations will be performed at baseline and after 4 months.
- Conditions
- Obstructive Sleep Apnea, Atherosclerosis
- Being tested
- Continuous positive airway pressure (CPAP)
- Keywords
- obstructive sleep apnea, arterial stiffness, atherosclerosis, CPAP, heart disease
- Medical subject headings
- Sleep Apnea, Obstructive, Atherosclerosis, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressure (CPAP)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial stiffness (evaluated by PWV)
Intima media thickness (IMT)
Carotid diameter (CD)
Secondary outcomes (3)
24h blood pressure monitoring
plasma catecholamine
C-reactive protein (CRP)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2006 (estimated)
- Study startJan 2004
- Study completionJul 2006
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Investigators
- Luciano F Drager, MD, Principal investigator, InCor Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400543
- Sponsor's protocol ID
- SDC 2431/04/051
- Status last verified
- Nov 2006
- First submitted
- 16 Nov 2006
- Last updated
- 17 Nov 2006
- Results posted
- No
Publications
Drager LF, Bortolotto LA, Figueiredo AC, Krieger EM, Lorenzi GF. Effects of continuous positive airway pressure on early signs of atherosclerosis in obstructive sleep apnea. Am J Respir Crit Care Med. 2007 Oct 1;176(7):706-12. doi: 10.1164/rccm.200703-500OC. Epub 2007 Jun 7.
PubMed 17556718