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Cardiovascular Impact of Obstructive Sleep Apnea Treatment in Normotensive Patients (OSA-NORMO)

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
CPAP
CPAP
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea, Blood Pressure, PreHypertension, Masked Hypertension

Eligibility Criteria

30 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Severe OSA patients

Exclusion Criteria:

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

Sites / Locations

  • Heart Institute (InCor)

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

1

2

Arm Description

Control group

CPAP

Outcomes

Primary Outcome Measures

Office Blood Pressure
Evaluation of PreHypertension

Secondary Outcome Measures

24 Hour Ambulatory Blood Pressure Monitoring
Evaluation of Masked Hypertension

Full Information

First Posted
August 25, 2008
Last Updated
October 27, 2010
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT00741520
Brief Title
Cardiovascular Impact of Obstructive Sleep Apnea Treatment in Normotensive Patients
Acronym
OSA-NORMO
Official Title
Cardiovascular Impact of Obstructive Sleep Apnea in Normotensive Patients and the Effects of Continuous Positive Airway Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obstructive Sleep Apnea, Blood Pressure, PreHypertension, Masked Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Control group
Arm Title
2
Arm Type
Active Comparator
Arm Description
CPAP
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
Control - no treatment
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
CPAP: The airway pressure will be determined by an overnight sleep study titration.
Primary Outcome Measure Information:
Title
Office Blood Pressure
Description
Evaluation of PreHypertension
Secondary Outcome Measure Information:
Title
24 Hour Ambulatory Blood Pressure Monitoring
Description
Evaluation of Masked Hypertension

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Severe OSA patients Exclusion Criteria: Smoking Sustained Hypertension Heart failure Diabetes Renal diseases Under use of any medication Under treatment for OSA
Facility Information:
Facility Name
Heart Institute (InCor)
City
Sao Paulo
ZIP/Postal Code
05403-904
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Cardiovascular Impact of Obstructive Sleep Apnea Treatment in Normotensive Patients

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