Continuous Positive Airway Pressure in Sleep Apnea Syndrome: Effects on Metabolic Syndrome and Cardiac Damage

Phase 4

• Conditions: Sleep Apnea Syndrome; Metabolic Syndrome; Cardiac Remodelling; Continuous Positive Airway Pressure Ventilation
• Interventions: Device: continuous positive airway pressure ventilation; Behavioral: dietary and life style recommendations

• Registration Number: NCT00517777
• Lead Sponsor: Università degli Studi dell'Insubria

Brief Summary

To assess in moderate to severe Obstructive Sleep Apnea the effects of one year therapy with nighttime continuous positive airway pressure ventilation on the prevalence of metabolic syndrome and cardiovascular damage.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-08
• Study Start: 2007-08
• Study First Submitted: 2007-08-15
• Study First Submitted QC: 2007-08-15
• Last Update Submitted: 2007-08-15
• Study First Posted: 2007-08-17
• Last Update Posted: 2007-08-17
• Study Completion: 2010-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• moderate to severe sleep apnea syndrome

Exclusion Criteria

• cardiovascular diseases (coronary artery disease, stroke, peripheral artery disease)
• thyroid diseases
• diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	dietary and life style recommendations	continuous positive airway pressure ventilation + dietary and life style recommendations
1	continuous positive airway pressure ventilation	continuous positive airway pressure ventilation + dietary and life style recommendations
2	dietary and life style recommendations	dietary and life style recommendations

Primary Outcome Measures

Name	Time	Method
metabolic syndrome	one year
left ventricular mass	one year
diastolic function	one year

Trial Locations

Locations (1)

University of Insubria-Department of Clinical Medicine; 🇮🇹 Varese, Italy