Effects of Obstructive Sleep Apnea Treatment by Fixed CPAP and by Auto-CPAP (Somnosmart2)
NCT ID: NCT00633711
Last Updated: 2011-06-16
Study Results
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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COMPLETED
PHASE4
17 participants
INTERVENTIONAL
2007-03-31
2010-03-31
Brief Summary
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Detailed Description
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Before starting treatment, a full night standard polysomnography will be performed: in subjects assigned to fixed CPAP for attended CPAP titration; in the other subjects during application of the Somnosmart2 device, to verify if obstructive events are adequately eliminated by it.
After analysis of polysomnography, patients will be given a fixed CPAP or the auto-CPAP device for nocturnal home use. Two months later, compliance to treatment will be verified measured by the in-built time counter of the devices. Then, cardiorespiratory monitoring during application of the device used for treatment, nocturnal urine collection and 24-hour ABPM will be repeated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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fixed CPAP
fixed continuous positive airway pressure (CPAP)
CPAP at a constant level, whose efficacy on respiratory disorders has been determined by nocturnal titration.
Home nocturnal usage. Two-month treatment.
Auto-CPAP
Auto-CPAP Weinmann "Somnosmart2"
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-month treatment.
Interventions
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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-month treatment.
fixed continuous positive airway pressure (CPAP)
CPAP at a constant level, whose efficacy on respiratory disorders has been determined by nocturnal titration.
Home nocturnal usage. Two-month treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
25 Years
60 Years
ALL
No
Sponsors
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Weinmann Geräte für Medizin GmbH + Co. KG
INDUSTRY
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
OTHER_GOV
Responsible Party
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National Research Council, Inst. of Biomedicine and Molecular Immunology, Italy
Principal Investigators
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Oreste Marrone, MD
Role: PRINCIPAL_INVESTIGATOR
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Locations
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National Research Council - Institute of Biomedicine and Molecular Immunology (CNR - IBIM)
Palermo, , Italy
Countries
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References
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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. doi: 10.1378/chest.06-2192.
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. doi: 10.1161/HYPERTENSIONAHA.106.085175. Epub 2007 Jun 4.
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. doi: 10.1007/s00408-006-0117-x. 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. doi: 10.1001/archinte.167.8.757.
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. doi: 10.1152/ajpregu.00400.2007. Epub 2007 Jul 25.
Narkiewicz K, Somers VK. Sympathetic nerve activity in obstructive sleep apnoea. Acta Physiol Scand. 2003 Mar;177(3):385-90. doi: 10.1046/j.1365-201X.2003.01091.x.
Other Identifiers
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CNR-IBIM-001
Identifier Type: -
Identifier Source: org_study_id
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