Impact of Obstructive Sleep Apnea Treatment in Patients With Metabolic Syndrome (TREATOSA-MS)

University of Sao Paulo

Status and phase: Completed; Phase 4

Conditions: Sleep Apnea; Metabolic Syndrome

Treatments: Device: Nasal strips; Device: CPAP (REMstar System One Plus - Philips Medical Systems)

Study type: Interventional

Funder types: Other

Identifiers

NCT02295202

SDC 4075/14/055

Details and patient eligibility

About

Obstructive Sleep Apnea (OSA) is a common condition that may induce hemodynamic and metabolic dysregulation. However, it is not clear if OSA is a mere epiphenomenon or contributes to increase the morbidity associated with metabolic syndrome. This study was designed to evaluate the impact of OSA treatment with CPAP in consecutive patients with metabolic syndrome.

Enrollment: 100 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Metabolic Syndrome (ATP III)
• Moderate to severe OSA

Exclusion criteria

• Smokers
• Patients under chronic use of medications
• Neurological diseases
• Coronary artery disease
• Acute heart failure
• Chronic renal failure (GFR < 30 ml/min)
• Chronic obstructive pulmonary disease
• Mild OSA and patients with BMI over 40 kg/m2.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

CPAP

Experimental group

Description:

CPAP: Continuous Positive Airway Pressure - Device used for treating OSA during sleep.

Treatment:

Device: CPAP (REMstar System One Plus - Philips Medical Systems)

Placebo

Placebo Comparator group

Description:

Nasal Strips

Treatment:

Device: Nasal strips