search
Back to results

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

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Automatic (variable, automatically controlled) pressure CPAP
fixed continuous positive airway pressure (CPAP)
Sponsored by
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome focused on measuring OSAS, blood pressure, sympathetic nervous system, treatment, CPAP

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Obstructive sleep apnea syndrome deserving CPAP treatment

Exclusion Criteria:

  • current pharmacological treatment

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

fixed CPAP

Auto-CPAP

Arm Description

Auto-CPAP Weinmann "Somnosmart2"

Outcomes

Primary Outcome Measures

Blood pressure and urinary catecholamines after conventional or auto-CPAP

Secondary Outcome Measures

Relationship between catecholamines / blood pressure changes and compliance to treatment

Full Information

First Posted
March 4, 2008
Last Updated
June 15, 2011
Sponsor
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Collaborators
Weinmann Geräte für Medizin GmbH + Co. KG
search

1. Study Identification

Unique Protocol Identification Number
NCT00633711
Brief Title
Effects of Obstructive Sleep Apnea Treatment by Fixed CPAP and by Auto-CPAP (Somnosmart2)
Official Title
Differential Effects of Chronic Treatment of OSAS by CPAP and SOMNOsmart2 on Norepinephrine and Blood Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Collaborators
Weinmann Geräte für Medizin GmbH + Co. KG

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
Keywords
OSAS, blood pressure, sympathetic nervous system, treatment, CPAP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fixed CPAP
Arm Type
Active Comparator
Arm Title
Auto-CPAP
Arm Type
Experimental
Arm Description
Auto-CPAP Weinmann "Somnosmart2"
Intervention Type
Device
Intervention Name(s)
Automatic (variable, automatically controlled) pressure CPAP
Other Intervention Name(s)
Automatic CPAP "SOMNOsmart2", Weinmann, Hamburg Germany
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
fixed continuous positive airway pressure (CPAP)
Other Intervention Name(s)
fixed CPAP, constant level CPAP
Intervention Description
CPAP at a constant level, whose efficacy on respiratory disorders has been determined by nocturnal titration. Home nocturnal usage. Two-month treatment.
Primary Outcome Measure Information:
Title
Blood pressure and urinary catecholamines after conventional or auto-CPAP
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Relationship between catecholamines / blood pressure changes and compliance to treatment
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Obstructive sleep apnea syndrome deserving CPAP treatment Exclusion Criteria: current pharmacological treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oreste Marrone, MD
Organizational Affiliation
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Research Council - Institute of Biomedicine and Molecular Immunology (CNR - IBIM)
City
Palermo
ZIP/Postal Code
90146
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
17494789
Citation
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.
Results Reference
background
PubMed Identifier
17548722
Citation
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.
Results Reference
background
PubMed Identifier
17393240
Citation
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.
Results Reference
background
PubMed Identifier
17452537
Citation
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.
Results Reference
background
PubMed Identifier
17652356
Citation
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.
Results Reference
background
PubMed Identifier
12609010
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs