Continuous Positive Airway Pressure in Sleep Apnea Syndrome: Effects on Metabolic Syndrome and Cardiac Damage - Full Text View

Sponsored by:	Università degli Studi dell'Insubria
Information provided by:	Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier:	NCT00517777

Purpose

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.

Condition	Intervention	Phase
Sleep Apnea Syndrome Metabolic Syndrome Cardiac Remodelling Continuous Positive Airway Pressure Ventilation	Device: continuous positive airway pressure ventilation Behavioral: dietary and life style recommendations	Phase IV

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Università degli Studi dell'Insubria:

Primary Outcome Measures:

metabolic syndrome [ Time Frame: one year ]
left ventricular mass [ Time Frame: one year ]
diastolic function [ Time Frame: one year ]

Estimated Enrollment:	100
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2010

Arms	Assigned Interventions
1: Experimental continuous positive airway pressure ventilation + dietary and life style recommendations	Device: continuous positive airway pressure ventilation nighttime Behavioral: dietary and life style recommendations
2: Active Comparator dietary and life style recommendations	Behavioral: dietary and life style recommendations

Eligibility

Ages Eligible for Study:	25 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

moderate to severe sleep apnea syndrome

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517777

Locations

Italy
University of Insubria-Department of Clinical Medicine	Recruiting
varese, Italy, 21100
Contact: anna maria grandi, MD +39+332 278594 amgrandi@libero.it
Sub-Investigator: andrea maria maresca, MD
Sub-Investigator: fausto colombo, MD
Sub-Investigator: francesco solbiati, MD
Sub-Investigator: emanuela laurita, MD

Sponsors and Collaborators

Università degli Studi dell'Insubria

Investigators

Principal Investigator:

anna maria grandi, MD

Università degli Studi dell'Insubria

More Information

Publications:

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.

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.

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.

Study ID Numbers:	1113
Study First Received:	August 15, 2007
Last Updated:	August 15, 2007
ClinicalTrials.gov Identifier:	NCT00517777
Health Authority:	Italy: Ethics Committee

Keywords provided by Università degli Studi dell'Insubria:

sleep apnea syndrome
metabolic syndrome
cardiac remodelling
continuous positive airway pressure ventilation

Study placed in the following topic categories:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders

Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009