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Completed

NCT Number: NCT00633711

Effects of Obstructive Sleep Apnea Treatment by Fixed CPAP and by Auto-CPAP (Somnosmart2)

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.

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Key information

Conditions

Obstructive Sleep Apnea Syndrome Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Research Council - Institute of Biomedicine and Molecular Immunology (CNR - IBIM)

Palermo, 90146, Italy

About this study

A nocturnal home cardiorespiratory recording will performed for diagnosis of OSA. During the same night, patients will be asked to collect their urines. Twentyfour-hour ambulatory BP monitoring (ABPM) will be performed starting from the next morning. After analysis of the polygraphic recording, subjects with AHI <15 will be excluded from the study, while CPAP will be proposed as a treatment to the other patients.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Obstructive sleep apnea syndrome deserving CPAP treatment

Exclusion criteria

  • current pharmacological treatment

Treatment and study plan

Automatic (variable, automatically controlled) pressure CPAP

Device

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.

Other names: Automatic CPAP "SOMNOsmart2", Weinmann, Hamburg Germany

fixed continuous positive airway pressure (CPAP)

Device

CPAP at a constant level, whose efficacy on respiratory disorders has been determined by nocturnal titration.

Home nocturnal usage. Two-month treatment.

Other names: fixed CPAP, constant level CPAP

Primary outcomes

  1. Blood pressure and urinary catecholamines after conventional or auto-CPAP

    Time frame: 2 months

Secondary outcomes

  1. Relationship between catecholamines / blood pressure changes and compliance to treatment

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

Other Gov

Collaborators

  • Weinmann Geräte für Medizin GmbH + Co. KG

Registry information

Official study title

Differential Effects of Chronic Treatment of OSAS by CPAP and SOMNOsmart2 on Norepinephrine and Blood Pressure

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Mar 12, 2008
Registry last updated
Jun 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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