Impact of Obstructive Sleep Apnea Treatment in Patients With Metabolic Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Sleep Apnea Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CPAP

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

Group Type EXPERIMENTAL

CPAP (REMstar System One Plus - Philips Medical Systems)

Intervention Type DEVICE

Standard device for treating obstructive sleep apnea.

Placebo

Nasal Strips

Group Type PLACEBO_COMPARATOR

Nasal strips

Intervention Type DEVICE

Interventions

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CPAP (REMstar System One Plus - Philips Medical Systems)

Standard device for treating obstructive sleep apnea.

Intervention Type DEVICE

Nasal strips

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No