The Effects of Continuous Positive Airway Pressure (CPAP) on Sympathetic Activity in Different Sites of Activation

NCT ID: NCT01336335

Last Updated: 2011-04-15

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-07-31

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 sympathetic system in apparently normotensive patients with OSA as well as the impact of treatment with continuous positive airway pressure in different sites of activation (heart, peripheral nerves and circulating catecholamines)

Detailed Description

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Conditions

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Radionuclide Imaging (MIBG Scintigraphy) Exercise Test Blood Pressure Monitoring, Ambulatory Sympathetic Nerve Activity Catecholamines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CPAP

OSA treatment with CPAP

Group Type EXPERIMENTAL

CPAP

Intervention Type DEVICE

CPAP

control

no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CPAP

CPAP

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Severe OSA males

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

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Universidade de São Paulo

Principal Investigators

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Rodrigo Pedrosa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Heart Institute (InCor)

Locations

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Heart Institute

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Sympathetic activity and OSA

Identifier Type: -

Identifier Source: org_study_id

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