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

Università degli Studi dell'Insubria

Status and phase: Unknown; Phase 4

Conditions: Continuous Positive Airway Pressure Ventilation; Cardiac Remodelling; Sleep Apnea Syndrome; Metabolic Syndrome

Treatments: Behavioral: dietary and life style recommendations; Device: continuous positive airway pressure ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT00517777

1113

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• moderate to severe sleep apnea syndrome

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

1

Experimental group

Description:

continuous positive airway pressure ventilation + dietary and life style recommendations

Treatment:

Behavioral: dietary and life style recommendations

Device: continuous positive airway pressure ventilation

Behavioral: dietary and life style recommendations

2

Active Comparator group

Description:

dietary and life style recommendations

Treatment:

Behavioral: dietary and life style recommendations

Behavioral: dietary and life style recommendations