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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00741520
First Posted: August 26, 2008
Last Update Posted: October 28, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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 (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:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Office Blood Pressure
    Evaluation of PreHypertension


Secondary Outcome Measures:
  • 24 Hour Ambulatory Blood Pressure Monitoring
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Geraldo Lorenzi-Filho, Heart Institute (InCor)
ClinicalTrials.gov Identifier: NCT00741520     History of Changes
Other Study ID Numbers: 2431/04/051
First Submitted: August 25, 2008
First Posted: August 26, 2008
Last Update Posted: October 28, 2010
Last Verified: August 2008

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 Wake Disorders
Nervous System Diseases