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

University of Sao Paulo

Status and phase: Completed; Phase 4

Conditions: Obstructive Sleep Apnea

Treatments: Device: CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT00741520

2431/04/051

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: Male

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Severe OSA patients

Exclusion criteria

• Smoking
• Sustained Hypertension
• Heart failure
• Diabetes
• Renal diseases
• Under use of any medication
• Under treatment for OSA

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Control group

Treatment:

Device: CPAP

Device: CPAP

2

Active Comparator group

Description:

CPAP

Treatment:

Device: CPAP

Device: CPAP