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Obstructive Sleep ApneaPhase 4NCT01635010

Obstructive Sleep Apnea in the Absence of Metabolic Syndrome

A Phase 4 study testing continuous positive airway pressure (CPAP) in people with Obstructive Sleep Apnea, run by Associação Fundo de Incentivo à Pesquisa at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Obstructive Sleep Apnea (OSA) is commonly associated with factors that increase cardiovascular risk, including Metabolic Syndrome (MS). There is a lack of well-controlled clinical studies investigating the independent effects of OSA in the development of cardiovascular disease, especially evaluating jointly mechanisms… Read more about this study

Who is it for?
Ages 25 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for
Obstructive Sleep Apnea
What is being tested?
continuous positive airway pressure (CPAP)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteBrazil
Study dates
Dec 2008to Dec 2011
Phase
Phase 4
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 25 to 60 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • male subjects
  • apnea-hypopnea index > 15/h (OSA group)
  • apnea-hypopnea index < 5/h (control group)

Who cannot join

  • body mass index (BMI) > 30 kg/m2
  • age > 60 years
  • chronic obstructive pulmonary disease
  • cardiac diseases
  • diabetes mellitus
  • metabolic syndrome according to modified National Cholesterol Education Program Adult Treatment Panel III criteria
  • previous OSA treatment

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Associação Fundo de Incentivo à Pesquisa

    São Paulo, São Paulo, 04020-060

Other trials in Brazil

About this study

Official title: Obstructive Sleep Apnea in the Absence of Metabolic Syndrome: Pulse Wave Velocity, Inflammatory and Oxidative Stress Markers

Obstructive Sleep Apnea (OSA) is commonly associated with factors that increase cardiovascular risk, including Metabolic Syndrome (MS). There is a lack of well-controlled clinical studies investigating the independent effects of OSA in the development of cardiovascular disease, especially evaluating jointly mechanisms involved in these disorders such as inflammatory response, oxidative stress and vascular changes. The investigators hypothesized that in the absence of MetS, the mechanisms involved on cardiovascular consequences in OSA patients would be less important.

The purpose of this study is to analyze the effects of OSA in the absence of MS, on inflammatory, oxidative stress and vascular markers; to verify the influence of excessive daytime sleepiness (EDS) on the same parameters; and additionally verify the effects of nasal continuous positive airway pressure (nCPAP)in theses parameters.

Being tested
continuous positive airway pressure (CPAP)
Keywords
obstructive sleep apnea, inflammation, oxidative stress, arterial stiffness
Medical subject headings
Sleep Apnea, Obstructive, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • continuous positive airway pressure (CPAP)Procedure or surgery

    CPAP pressure is individually prescript according to polysomnography for CPAP titration

Study groups in NCT01635010
Study groupRoleWhat they receive
ControlNo interventionNot described
Obstructive sleep apneaExperimentalNot described
Receives: Procedure: continuous positive airway pressure (CPAP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inflammatory marker (high sensitive C-reactive protein)

    Measured: 3 months

  2. Oxidative stress marker (homocysteine, cysteine and paraoxonase-1 activity)

    Measured: 3 months

  3. Arterial stiffness (pulse wave velocity)

    Measured: 3 months

  4. Angiotensin converting enzyme activity

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2012 (estimated)
  2. Study startDec 2008
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01635010
Sponsor's protocol ID
ASSIMVOP012
Status last verified
Jul 2012
First submitted
29 Jun 2012
Last updated
6 Jul 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing continuous positive airway pressure (CPAP) 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 3 inclusion and 7 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 6 Jul 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Inflammatory marker (high sensitive C-reactive protein) (time frame: 3 months). The study lists 4 primary outcomes in all. 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 NCT01635010.

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 6 Jul 2012.

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