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

June 15, 2011 updated by: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Palermo, Italy, 90146
        • National Research Council - Institute of Biomedicine and Molecular Immunology (CNR - IBIM)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Obstructive sleep apnea syndrome deserving CPAP treatment

Exclusion Criteria:

  • current pharmacological treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Automatic CPAP "SOMNOsmart2", Weinmann, Hamburg Germany

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood pressure and urinary catecholamines after conventional or auto-CPAP
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Relationship between catecholamines / blood pressure changes and compliance to treatment
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Weinmann Geräte für Medizin GmbH + Co. KG

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

March 1, 2010

Study Registration Dates

First Submitted

March 4, 2008

First Submitted That Met QC Criteria

March 4, 2008

First Posted (ESTIMATE)

March 12, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 16, 2011

Last Update Submitted That Met QC Criteria

June 15, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNR-IBIM-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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