Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00741520
Recruitment Status : Completed
First Posted : August 26, 2008
Last Update Posted : October 28, 2010
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

Tracking Information
First Submitted Date  ICMJE August 25, 2008
First Posted Date  ICMJE August 26, 2008
Last Update Posted Date October 28, 2010
Study Start Date  ICMJE August 2008
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2010)
Office Blood Pressure
Evaluation of PreHypertension
Original Primary Outcome Measures  ICMJE
 (submitted: August 25, 2008)
Blood pressure measurements (24-hour ambulatory blood pressure measurements) [ Time Frame: Baseline and after 3 months. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2010)
24 Hour Ambulatory Blood Pressure Monitoring
Evaluation of Masked Hypertension
Original Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2008)
  • urine volume and microalbuminuria [ Time Frame: Baseline and after 3 months. ]
  • arterial stiffness [ Time Frame: Baseline and after 3 months ]
  • Baroreflex sensitivity [ Time Frame: Baseline and after 3 months ]
  • Blood pressure response during treadmill testing [ Time Frame: Baseline and after 3 months ]
  • Sympathetic activity [ Time Frame: Baseline and after 3 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cardiovascular Impact of Obstructive Sleep Apnea Treatment in Normotensive Patients
Official Title  ICMJE Cardiovascular Impact of Obstructive Sleep Apnea in Normotensive Patients and the Effects of Continuous Positive Airway Pressure
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Obstructive Sleep Apnea
Intervention  ICMJE
  • Device: CPAP
    Control - no treatment
  • Device: CPAP
    CPAP: The airway pressure will be determined by an overnight sleep study titration.
Study Arms  ICMJE
  • Placebo Comparator: 1
    Control group
    Intervention: Device: CPAP
  • Active Comparator: 2
    CPAP
    Intervention: Device: CPAP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 27, 2010)
36
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2008)
40
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Severe OSA patients

Exclusion Criteria:

  • Smoking
  • Sustained Hypertension
  • Heart failure
  • Diabetes
  • Renal diseases
  • Under use of any medication
  • Under treatment for OSA
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00741520
Other Study ID Numbers  ICMJE 2431/04/051
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Geraldo Lorenzi-Filho, Heart Institute (InCor)
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE
  • Fundação de Amparo à Pesquisa do Estado de São Paulo
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators  ICMJE Not Provided
PRS Account University of Sao Paulo
Verification Date August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP