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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Università degli Studi dell'Insubria.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier:
NCT00517777
First received: August 15, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  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 4

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

Resource links provided by NLM:

U.S. FDA Resources

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

ClinicalTrials.gov Identifier: NCT00517777     History of Changes
Other Study ID Numbers: 1113
Study First Received: August 15, 2007
Last Updated: August 15, 2007
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

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Metabolic Syndrome X
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
 Dyssomnias
Sleep Disorders
Nervous System Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013