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NCT00517777 Clinical Trial

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

Metabolic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00517777
Other study ID # 1113
Secondary ID
Status Recruiting
Phase Phase 4
First received August 15, 2007
Last updated August 15, 2007
Start date August 2007
Est. completion date August 2010

Study information
Verified date August 2007
Source Università degli Studi dell'Insubria
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date August 2010
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 25 Years to 70 Years
Eligibility Inclusion Criteria:

- moderate to severe sleep apnea syndrome

Exclusion Criteria:

- cardiovascular diseases (coronary artery disease, stroke, peripheral artery disease)

- thyroid diseases

- diabetes

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• continuous positive airway pressure ventilation
nighttime
Behavioral:
• dietary and life style recommendations

• dietary and life style recommendations

Locations
Country Name City State
Italy University of Insubria-Department of Clinical Medicine Varese

Sponsors (1)
Lead Sponsor Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View 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. Review. — View 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. Epub 2006 Apr 3. — View 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. Epub 2006 Mar 15. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary metabolic syndrome one year
Primary left ventricular mass one year
Primary diastolic function one year
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