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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. The completion date has passed and the status has not been verified in more than two years.
Verified August 2007 by Università degli Studi dell'Insubria.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00517777
First Posted: August 17, 2007
Last Update Posted: August 17, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Università degli Studi dell'Insubria
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: August 15, 2007
First Posted: August 17, 2007
Last Update Posted: August 17, 2007
Last Verified: August 2007

Keywords provided by Università degli Studi dell'Insubria:
sleep apnea syndrome
metabolic syndrome
cardiac remodelling
continuous positive airway pressure ventilation

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