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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
August 15, 2007
August 17, 2007
August 17, 2007
August 2007
Not Provided
  • metabolic syndrome [ Time Frame: one year ]
  • left ventricular mass [ Time Frame: one year ]
  • diastolic function [ Time Frame: one year ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Continuous Positive Airway Pressure in Sleep Apnea Syndrome: Effects on Metabolic Syndrome and Cardiac Damage
Effects of the Continuous Positive Airway Pressure Ventilation on the Prevalence of the Metabolic Syndrome and Cardiac Morpho-Functional Characteristics in Sleep Apnea Syndrome
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Sleep Apnea Syndrome
  • Metabolic Syndrome
  • Cardiac Remodelling
  • Continuous Positive Airway Pressure Ventilation
  • Device: continuous positive airway pressure ventilation
    nighttime
  • Behavioral: dietary and life style recommendations
  • Experimental: 1
    continuous positive airway pressure ventilation + dietary and life style recommendations
    Interventions:
    • Device: continuous positive airway pressure ventilation
    • Behavioral: dietary and life style recommendations
  • Active Comparator: 2
    dietary and life style recommendations
    Intervention: Behavioral: dietary and life style recommendations

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
100
August 2010
Not Provided

Inclusion Criteria:

  • moderate to severe sleep apnea syndrome

Exclusion Criteria:

  • cardiovascular diseases (coronary artery disease, stroke, peripheral artery disease)
  • thyroid diseases
  • diabetes
Sexes Eligible for Study: All
25 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00517777
1113
Yes
Not Provided
Not Provided
Not Provided
Università degli Studi dell'Insubria
Not Provided
Principal Investigator: anna maria grandi, MD Università degli Studi dell'Insubria
Università degli Studi dell'Insubria
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP