- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00517777
Continuous Positive Airway Pressure in Sleep Apnea Syndrome: Effects on Metabolic Syndrome and Cardiac Damage
August 15, 2007 updated by: Università degli Studi dell'Insubria
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.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Varese, Italy, 21100
- Recruiting
- University of Insubria-Department of Clinical Medicine
-
Sub-Investigator:
- fausto colombo, MD
-
Sub-Investigator:
- francesco solbiati, MD
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Sub-Investigator:
- emanuela laurita, MD
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- moderate to severe sleep apnea syndrome
Exclusion Criteria:
- cardiovascular diseases (coronary artery disease, stroke, peripheral artery disease)
- thyroid diseases
- diabetes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
continuous positive airway pressure ventilation + dietary and life style recommendations
|
nighttime
|
ACTIVE_COMPARATOR: 2
dietary and life style recommendations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
metabolic syndrome
Time Frame: one year
|
one year
|
left ventricular mass
Time Frame: one year
|
one year
|
diastolic function
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. doi: 10.1161/01.CIR.0000111245.75752.C6. No abstract available.
- 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. doi: 10.1378/chest.124.2.594.
- 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. doi: 10.1161/01.HYP.0000217128.41284.78. 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. doi: 10.1016/j.jacc.2005.11.054. Epub 2006 Mar 15.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Study Completion (ANTICIPATED)
August 1, 2010
Study Registration Dates
First Submitted
August 15, 2007
First Submitted That Met QC Criteria
August 15, 2007
First Posted (ESTIMATE)
August 17, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
August 17, 2007
Last Update Submitted That Met QC Criteria
August 15, 2007
Last Verified
August 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Disease
- Signs and Symptoms, Respiratory
- Insulin Resistance
- Hyperinsulinism
- Sleep Apnea Syndromes
- Syndrome
- Apnea
- Metabolic Syndrome
Other Study ID Numbers
- 1113
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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