NCT00633711

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 4, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

June 16, 2011

Status Verified

April 1, 2010

Enrollment Period

2.8 years

First QC Date

March 4, 2008

Last Update Submit

June 15, 2011

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

OSASblood pressuresympathetic nervous systemtreatmentCPAP

Outcome Measures

Primary Outcomes (1)

  • Blood pressure and urinary catecholamines after conventional or auto-CPAP

    2 months

Secondary Outcomes (1)

  • Relationship between catecholamines / blood pressure changes and compliance to treatment

    2 months

Study Arms (2)

fixed CPAP

ACTIVE COMPARATOR
Device: fixed continuous positive airway pressure (CPAP)

Auto-CPAP

EXPERIMENTAL

Auto-CPAP Weinmann "Somnosmart2"

Device: Automatic (variable, automatically controlled) pressure CPAP

Interventions

Automatic (variable, automatically controlled) pressure CPAPDEVICE

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.

Also known as: Automatic CPAP "SOMNOsmart2", Weinmann, Hamburg Germany
Auto-CPAP
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.

Also known as: fixed CPAP, constant level CPAP
fixed CPAP

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Obstructive sleep apnea syndrome deserving CPAP treatment

You may not qualify if:

  • current pharmacological treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Palermo, 90146, Italy

Location

Related Publications (6)

  • 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.

    PMID: 17494789BACKGROUND

  • 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.

    PMID: 17548722BACKGROUND

  • 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.

    PMID: 17393240BACKGROUND

  • 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.

    PMID: 17452537BACKGROUND

  • 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.

    PMID: 17652356BACKGROUND

  • 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.

    PMID: 12609010BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Oreste Marrone, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 4, 2008

First Posted

March 12, 2008

Study Start

March 1, 2007

Primary Completion

December 1, 2009

Study Completion

March 1, 2010

Last Updated

June 16, 2011

Record last verified: 2010-04

Locations

IT(1)