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

NCT00633711 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2011-06-16

No results posted yet for this study

Summary

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.

Conditions

  • Obstructive Sleep Apnea Syndrome

Interventions

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-month treatment.

DEVICE

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.

Sponsors & Collaborators

  • Weinmann Geräte für Medizin GmbH + Co. KG

    collaborator INDUSTRY

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

    lead OTHER_GOV

Principal Investigators

  • Oreste Marrone, MD · Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-12-31
Completion
2010-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00633711 on ClinicalTrials.gov