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

Primary Purpose

Sleep Apnea Syndrome, Metabolic Syndrome, Cardiac Remodelling

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
continuous positive airway pressure ventilation
dietary and life style recommendations
dietary and life style recommendations
Sponsored by
Università degli Studi dell'Insubria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea Syndrome focused on measuring sleep apnea syndrome, metabolic syndrome, cardiac remodelling, continuous positive airway pressure ventilation

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • moderate to severe sleep apnea syndrome

Exclusion Criteria:

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

Sites / Locations

  • University of Insubria-Department of Clinical MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

continuous positive airway pressure ventilation + dietary and life style recommendations

dietary and life style recommendations

Outcomes

Primary Outcome Measures

metabolic syndrome
left ventricular mass
diastolic function

Secondary Outcome Measures

Full Information

First Posted
August 15, 2007
Last Updated
August 15, 2007
Sponsor
Università degli Studi dell'Insubria
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1. Study Identification

Unique Protocol Identification Number
NCT00517777
Brief Title
Continuous Positive Airway Pressure in Sleep Apnea Syndrome: Effects on Metabolic Syndrome and Cardiac Damage
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Unknown status
Study Start Date
August 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Università degli Studi dell'Insubria

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndrome, Metabolic Syndrome, Cardiac Remodelling, Continuous Positive Airway Pressure Ventilation
Keywords
sleep apnea syndrome, metabolic syndrome, cardiac remodelling, continuous positive airway pressure ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
continuous positive airway pressure ventilation + dietary and life style recommendations
Arm Title
2
Arm Type
Active Comparator
Arm Description
dietary and life style recommendations
Intervention Type
Device
Intervention Name(s)
continuous positive airway pressure ventilation
Intervention Description
nighttime
Intervention Type
Behavioral
Intervention Name(s)
dietary and life style recommendations
Intervention Type
Behavioral
Intervention Name(s)
dietary and life style recommendations
Primary Outcome Measure Information:
Title
metabolic syndrome
Time Frame
one year
Title
left ventricular mass
Time Frame
one year
Title
diastolic function
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: moderate to severe sleep apnea syndrome Exclusion Criteria: cardiovascular diseases (coronary artery disease, stroke, peripheral artery disease) thyroid diseases diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
anna maria grandi, MD
Organizational Affiliation
Università degli Studi dell'Insubria
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Insubria-Department of Clinical Medicine
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
anna maria grandi, MD
Phone
+39+332 278594
Email
amgrandi@libero.it
First Name & Middle Initial & Last Name & Degree
andrea maria maresca, MD
First Name & Middle Initial & Last Name & Degree
fausto colombo, MD
First Name & Middle Initial & Last Name & Degree
francesco solbiati, MD
First Name & Middle Initial & Last Name & Degree
emanuela laurita, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
14744958
Citation
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.
Results Reference
background
PubMed Identifier
12907548
Citation
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.
Results Reference
background
PubMed Identifier
16585412
Citation
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.
Results Reference
background
PubMed Identifier
16580533
Citation
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.
Results Reference
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Continuous Positive Airway Pressure in Sleep Apnea Syndrome: Effects on Metabolic Syndrome and Cardiac Damage

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