- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00741520
Cardiovascular Impact of Obstructive Sleep Apnea Treatment in Normotensive Patients (OSA-NORMO)
October 27, 2010 updated by: University of Sao Paulo
Cardiovascular Impact of Obstructive Sleep Apnea in Normotensive Patients and the Effects of Continuous Positive Airway Pressure
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 4
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
-
-
-
Sao Paulo, Brazil, 05403-904
- Heart Institute (InCor)
-
-
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 patients
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 1
Control group
|
Control - no treatment
CPAP: The airway pressure will be determined by an overnight sleep study titration.
|
Active Comparator: 2
CPAP
|
Control - no treatment
CPAP: The airway pressure will be determined by an overnight sleep study titration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
Office Blood Pressure
|
Evaluation of PreHypertension
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
24 Hour Ambulatory Blood Pressure Monitoring
|
Evaluation of Masked Hypertension
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
August 1, 2008
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
August 25, 2008
First Submitted That Met QC Criteria
August 25, 2008
First Posted (Estimate)
August 26, 2008
Study Record Updates
Last Update Posted (Estimate)
October 28, 2010
Last Update Submitted That Met QC Criteria
October 27, 2010
Last Verified
August 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2431/04/051
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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