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

NCT00517777 | Unknown Phase 4 DMC

• 1 other identifier: 1113
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• metabolic syndrome

  one year

• left ventricular mass

  one year

• diastolic function

  one year

Study Arms (2)

1

EXPERIMENTAL

continuous positive airway pressure ventilation + dietary and life style recommendations

Device: continuous positive airway pressure ventilation; Behavioral: dietary and life style recommendations

2

ACTIVE COMPARATOR

dietary and life style recommendations

Behavioral: dietary and life style recommendations

Interventions

continuous positive airway pressure ventilation DEVICE

nighttime

1

dietary and life style recommendations BEHAVIORAL

2

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• moderate to severe sleep apnea syndrome

You may not qualify if:

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

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

Study Sites (1)

University of Insubria-Department of Clinical Medicine

Varese, 21100, Italy

RECRUITING

Related Publications (4)

• 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.

  PMID: 14744958 BACKGROUND

• 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.

  PMID: 12907548 BACKGROUND

• 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.

  PMID: 16585412 BACKGROUND

• 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.

  PMID: 16580533 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea Syndromes; Metabolic Syndrome

Interventions

Continuous Positive Airway Pressure; Diet

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• anna maria grandi, MD

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 15, 2007
• First Posted: August 17, 2007
• Study Start: August 1, 2007
• Study Completion: August 1, 2010
• Last Updated: August 17, 2007

Record last verified: 2007-08

Locations

IT (1)