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

April 13, 2011 updated by: University of Sao Paulo
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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Severe OSA males

Exclusion Criteria:

  • Smoking

    • Sustained Hypertension
    • Heart failure
    • Diabetes
    • Renal diseases
    • Under use of any medication
    • Under treatment for OSA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
no intervention
Experimental: CPAP
OSA treatment with CPAP
Device: CPAP
CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improvement in sympathetic activity in muscle sympathetic nerve activity (MSNA)
Time Frame: 3 months
Improvement in MSNA will be quantified as burst frequency over time (bursts per minute) and as burst frequency corrected for heart rate values (bursts per 100 heartbeats)in the begining and after 3 months.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improvement in sympathetic activity evaluated in different sites of activation
Time Frame: 3 months

All measurement will be performed at the begining and after 3 months. Blood: blood and 24 hour urine will be collected for norepinephrine quantification.

Heart: Early (15 min) and delayed (3 hr) planar images will be taken after injection of (123)I-MIBG. The mean counts of the whole heart and the mediastinum will be obtained to calculate heart-to-mediastinum count ratios from the early images (H/Me) and from the delayed images (H/Md) and the myocardial washout rate (WR).

Blood pressure: 24 hour ambulatory blood pressure monitoring and blood pressure during exercise test (treadmill test)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Rodrigo Pedrosa, MD, PhD, Heart Institute (InCor)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

July 1, 2011

Study Completion (Anticipated)

July 1, 2011

Study Registration Dates

First Submitted

April 13, 2011

First Submitted That Met QC Criteria

April 13, 2011

First Posted (Estimate)

April 15, 2011

Study Record Updates

Last Update Posted (Estimate)

April 15, 2011

Last Update Submitted That Met QC Criteria

April 13, 2011

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Sympathetic activity and OSA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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