Clinical trial NCT00517777: Continuous Positive Airway Pressure in Sleep Apnea Syndrome: Effects on Metabolic Syndrome and Cardiac Damage
Official title: Effects of the Continuous Positive Airway Pressure Ventilation on the Prevalence of the Metabolic Syndrome and Cardiac Morpho-Functional Characteristics in Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sleep Apnea Syndrome
Metabolic Syndrome
Cardiac Remodelling
Continuous Positive Airway Pressure Ventilation
Keywords: sleep apnea syndrome
metabolic syndrome
cardiac remodelling
continuous positive airway pressure ventilation
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2007-08-17
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* moderate to severe sleep apnea syndrome

Exclusion Criteria:

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

Primary outcomes:
measure: metabolic syndrome
timeFrame: one year
measure: left ventricular mass
timeFrame: one year
measure: diastolic function
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Varese
country: Italy
facility: University of Insubria-Department of Clinical Medicine
Study officials:
affiliation: Università degli Studi dell'Insubria
name: anna maria grandi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grundy SM, Brewer HB Jr, Cleeman JI, Smith SC Jr, Lenfant C; American Heart Association; National Heart, Lung, and Blood Institute. Definition of metabolic syndrome: Report of the National Heart, Lung, and Blood Institute/American Heart Association conference on scientific issues related to definition. Circulation. 2004 Jan 27;109(3):433-8. doi: 10.1161/01.CIR.0000111245.75752.C6. No abstract available.
citation: Cloward TV, Walker JM, Farney RJ, Anderson JL. Left ventricular hypertrophy is a common echocardiographic abnormality in severe obstructive sleep apnea and reverses with nasal continuous positive airway pressure. Chest. 2003 Aug;124(2):594-601. doi: 10.1378/chest.124.2.594.
citation: Norman D, Loredo JS, Nelesen RA, Ancoli-Israel S, Mills PJ, Ziegler MG, Dimsdale JE. Effects of continuous positive airway pressure versus supplemental oxygen on 24-hour ambulatory blood pressure. Hypertension. 2006 May;47(5):840-5. doi: 10.1161/01.HYP.0000217128.41284.78. Epub 2006 Apr 3.
citation: Shivalkar B, Van de Heyning C, Kerremans M, Rinkevich D, Verbraecken J, De Backer W, Vrints C. Obstructive sleep apnea syndrome: more insights on structural and functional cardiac alterations, and the effects of treatment with continuous positive airway pressure. J Am Coll Cardiol. 2006 Apr 4;47(7):1433-9. doi: 10.1016/j.jacc.2005.11.054. Epub 2006 Mar 15.