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

This study has been completed.
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00741520
First received: August 25, 2008
Last updated: October 27, 2010
Last verified: August 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Obstructive Sleep Apnea
 Device: CPAP
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Cardiovascular Impact of Obstructive Sleep Apnea in Normotensive Patients and the Effects of Continuous Positive Airway Pressure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Office Blood Pressure [ Designated as safety issue: No ]
    Evaluation of PreHypertension


Secondary Outcome Measures:
  • 24 Hour Ambulatory Blood Pressure Monitoring [ Designated as safety issue: No ]
    Evaluation of Masked Hypertension


Enrollment: 36
Study Start Date: August 2008
Study Completion Date: July 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Control group
 Device: CPAP
Control - no treatment
Active Comparator: 2
CPAP
 Device: CPAP
CPAP: The airway pressure will be determined by an overnight sleep study titration.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741520

Locations
Brazil
Heart Institute (InCor)
Sao Paulo, Brazil, 05403-904
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
  More Information

No publications provided

Responsible Party: Geraldo Lorenzi-Filho, Heart Institute (InCor)
ClinicalTrials.gov Identifier: NCT00741520     History of Changes
Other Study ID Numbers: 2431/04/051
Study First Received: August 25, 2008
Last Updated: October 27, 2010
Health Authority: Brazil: Ministry of Health

Keywords provided by University of Sao Paulo:
Obstructive Sleep Apnea
Blood Pressure
PreHypertension
Masked Hypertension

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013