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Cardiovascular Impact of Obstructive Sleep Apnea Treatment in Normotensive Patients

NCT ID: NCT00741520

Last Updated: 2010-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-07-31

Brief Summary

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Recent evidences suggest that obstructive sleep apnea (OSA) can contribute to cardiovascular disease even in the absence of hypertension. However, there are few data regarding the impact of OSA on the preHypertension and Masked Hypertension in apparently normotensive patients with OSA as well as the impact of treatment with continuous positive airway pressure.

Detailed Description

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Conditions

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Obstructive Sleep Apnea

Keywords

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Obstructive Sleep Apnea Blood Pressure PreHypertension Masked Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Control group

Group Type PLACEBO_COMPARATOR

CPAP

Intervention Type DEVICE

Control - no treatment

2

CPAP

Group Type ACTIVE_COMPARATOR

CPAP

Intervention Type DEVICE

CPAP: The airway pressure will be determined by an overnight sleep study titration.

Interventions

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CPAP

Control - no treatment

Intervention Type DEVICE

CPAP

CPAP: The airway pressure will be determined by an overnight sleep study titration.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Severe OSA patients

Exclusion Criteria

* Smoking
* Sustained Hypertension
* Heart failure
* Diabetes
* Renal diseases
* Under use of any medication
* Under treatment for OSA
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Heart Institute (InCor)

Locations

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Heart Institute (InCor)

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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2431/04/051

Identifier Type: -

Identifier Source: org_study_id