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

This study has been completed.
Sponsor:
Collaborator:
Weinmann Geräte für Medizin GmbH + Co. KG
Information provided by:
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
ClinicalTrials.gov Identifier:
NCT00633711
First received: March 4, 2008
Last updated: June 15, 2011
Last verified: April 2010
  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: Automatic (variable, automatically controlled) pressure CPAP
Device: fixed continuous positive airway pressure (CPAP)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Differential Effects of Chronic Treatment of OSAS by CPAP and SOMNOsmart2 on Norepinephrine and Blood Pressure

Resource links provided by NLM:


Further study details as provided by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, 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 ]

Enrollment: 17
Study Start Date: March 2007
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: fixed CPAP 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.

Other Name: fixed CPAP, constant level CPAP
Experimental: Auto-CPAP
Auto-CPAP Weinmann "Somnosmart2"
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.

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

Detailed Description:

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.

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Italy
National Research Council - Institute of Biomedicine and Molecular Immunology (CNR - IBIM)
Palermo, Italy, 90146
Sponsors and Collaborators
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Weinmann Geräte für Medizin GmbH + Co. KG
Investigators
Principal Investigator: Oreste Marrone, MD Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
  More Information

Publications:
Responsible Party: Dr Oreste Marrone, National Research Council, Inst. of Biomedicine and Molecular Immunology, Italy
ClinicalTrials.gov Identifier: NCT00633711     History of Changes
Other Study ID Numbers: CNR-IBIM-001
Study First Received: March 4, 2008
Last Updated: June 15, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy:
OSAS
blood pressure
sympathetic nervous system
treatment
CPAP

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on October 19, 2014