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NCT00741520 Clinical Trial

Cardiovascular Impact of Obstructive Sleep Apnea Treatment in Normotensive Patients

Obstructive Sleep Apnea Clinical Trial

— OSA-NORMO  

Official title:
Cardiovascular Impact of Obstructive Sleep Apnea in Normotensive Patients and the Effects of Continuous Positive Airway Pressure

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00741520
Other study ID # 2431/04/051
Secondary ID
Status Completed
Phase Phase 4
First received August 25, 2008
Last updated October 27, 2010
Start date August 2008
Est. completion date July 2010

Study information
Verified date August 2008
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date July 2010
Est. primary completion date March 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 30 Years to 60 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• CPAP
Control - no treatment
• CPAP
CPAP: The airway pressure will be determined by an overnight sleep study titration.

Locations
Country Name City State
Brazil Heart Institute (InCor) Sao Paulo

Sponsors (3)
Lead Sponsor Collaborator
University of Sao Paulo Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Office Blood Pressure Evaluation of PreHypertension No
Secondary 24 Hour Ambulatory Blood Pressure Monitoring Evaluation of Masked Hypertension No
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