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

NCT ID: NCT00517777

Last Updated: 2007-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Apnea Syndrome Metabolic Syndrome Cardiac Remodelling Continuous Positive Airway Pressure Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

continuous positive airway pressure ventilation + dietary and life style recommendations

Group Type EXPERIMENTAL

continuous positive airway pressure ventilation

Intervention Type DEVICE

nighttime

dietary and life style recommendations

Intervention Type BEHAVIORAL

2

dietary and life style recommendations

Group Type ACTIVE_COMPARATOR

dietary and life style recommendations

Intervention Type BEHAVIORAL

Interventions

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continuous positive airway pressure ventilation

nighttime

Intervention Type DEVICE

dietary and life style recommendations

Intervention Type BEHAVIORAL

dietary and life style recommendations

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* moderate to severe sleep apnea syndrome

Exclusion Criteria

* cardiovascular diseases (coronary artery disease, stroke, peripheral artery disease)
* thyroid diseases
* diabetes
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi dell'Insubria

OTHER

Sponsor Role lead

Principal Investigators

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anna maria grandi, MD

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi dell'Insubria

Locations

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University of Insubria-Department of Clinical Medicine

Varese, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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anna maria grandi, MD

Role: primary

[email protected]
+39+332 278594

References

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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.

Reference Type BACKGROUND
PMID: 14744958 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12907548 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16585412 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16580533 (View on PubMed)

Other Identifiers

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1113

Identifier Type: -

Identifier Source: org_study_id