Effects of Obstructive Sleep Apnea Syndrome (OSAS) Treatment by Constant Level Continuous Positive Airway Pressure (CPAP) and by Auto-CPAP (Somnosmart2) - Full Text View

Sponsors and Collaborators:	National Research Council, Italy Weinmann Geräte für Medizin, Hamburg, Germany
Information provided by:	National Research Council, Italy
ClinicalTrials.gov Identifier:	NCT00633711

Purpose

The main purpose of this study is to investigate if treatment of obstructive sleep apnea syndrome (OSAS) by continuous positive airway pressure (CPAP) given by a traditional CPAP device administering a fixed air pressure, or by one automatic CPAP device ("Somnosmart2", Weinmann, Hamburg) administering variable pressures, have different effects on sympathetic nervous system tone (as reflected by urinary excretion of norepinephrine and its catabolite normetanephrine) and on blood pressure.

Condition	Intervention	Phase
Obstructive Sleep Apnea Syndrome	Device: Conventional (constant level) CPAP Device: Automatic (variable, automatically controlled) pressure CPAP	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
Official Title:	Differential Effects of Chronic Treatment of OSAS by CPAP and SOMNOsmart2 on Norepinephrine and Blood Pressure

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Further study details as provided by National Research Council, Italy:

Primary Outcome Measures:

Blood pressure and urinary catecholamines after conventional or auto-CPAP [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Relationship between catecholamines / blood pressure changes and compliance to treatment [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	March 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Device: Conventional (constant level) CPAP CPAP pressure level effective on sleep respiratory disorders, as evaluated during nocturnal titration polysomnography. Home nocturnal usage. Two months treatment.
2: Experimental	Device: Automatic (variable, automatically controlled) pressure CPAP CPAP at a variable level according to instantaneous patients' needs for treatment of sleep respiratory disorders, as evaluated by machine's software. Home nocturnal usage. Two months treatment.

Eligibility

Ages Eligible for Study:	25 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Obstructive sleep apnea syndrome deserving CPAP treatment

Exclusion Criteria:

current pharmacological treatment
morbid obesity (BMI>45 kg/m2)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633711

Contacts

Contact: Oreste Marrone, MD

marrone@ibim.cnr.it

Locations

Italy
National Research Council - Institute of Biomedicine and Molecular Immunology (CNR - IBIM)	Recruiting
Palermo, Italy, 90146
Contact marrone@ibim.cnr.it
Principal Investigator: Oreste Marrone, MD

Sponsors and Collaborators

National Research Council, Italy

Weinmann Geräte für Medizin, Hamburg, Germany

Investigators

Principal Investigator:

Oreste Marrone, MD

National Research Council, Italy

More Information

Publications:

Patruno V, Aiolfi S, Costantino G, Murgia R, Selmi C, Malliani A, Montano N. Fixed and autoadjusting continuous positive airway pressure treatments are not similar in reducing cardiovascular risk factors in patients with obstructive sleep apnea. Chest. 2007 May;131(5):1393-9.

Bazzano LA, Khan Z, Reynolds K, He J. Effect of nocturnal nasal continuous positive airway pressure on blood pressure in obstructive sleep apnea. Hypertension. 2007 Aug;50(2):417-23. Epub 2007 Jun 4. Review.

Alajmi M, Mulgrew AT, Fox J, Davidson W, Schulzer M, Mak E, Ryan CF, Fleetham J, Choi P, Ayas NT. Impact of continuous positive airway pressure therapy on blood pressure in patients with obstructive sleep apnea hypopnea: a meta-analysis of randomized controlled trials. Lung. 2007 Mar-Apr;185(2):67-72. Epub 2007 Mar 28.

Haentjens P, Van Meerhaeghe A, Moscariello A, De Weerdt S, Poppe K, Dupont A, Velkeniers B. The impact of continuous positive airway pressure on blood pressure in patients with obstructive sleep apnea syndrome: evidence from a meta-analysis of placebo-controlled randomized trials. Arch Intern Med. 2007 Apr 23;167(8):757-64.

Parati G, Lombardi C, Narkiewicz K. Sleep apnea: epidemiology, pathophysiology, and relation to cardiovascular risk. Am J Physiol Regul Integr Comp Physiol. 2007 Oct;293(4):R1671-83. Epub 2007 Jul 25. Review.

Narkiewicz K, Somers VK. Sympathetic nerve activity in obstructive sleep apnoea. Acta Physiol Scand. 2003 Mar;177(3):385-90. Review.

Responsible Party:	National Research Council, Inst. of Biomedicine and Molecular Immunology, Italy ( Dr Oreste Marrone )
Study ID Numbers:	CNR-IBIM-001
Study First Received:	March 4, 2008
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00633711 History of Changes
Health Authority:	Italy: Ethics Committee

Keywords provided by National Research Council, Italy:

OSAS
blood pressure
sympathetic nervous system
treatment
CPAP

Study placed in the following topic categories:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Norepinephrine
Respiration Disorders

Sleep Apnea, Obstructive
Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Sleep Apnea Syndromes
Disease
Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Nervous System Diseases
Dyssomnias

Sleep Disorders
Sleep Disorders, Intrinsic
Signs and Symptoms
Pathologic Processes
Respiratory Tract Diseases
Syndrome
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on September 10, 2009