Obstructive Sleep Apnea SyndromePhase 4NCT00633711
Effects of Obstructive Sleep Apnea Treatment by Fixed CPAP and by Auto-CPAP (Somnosmart2)
A Phase 4 study testing fixed continuous positive airway pressure (CPAP) in people with Obstructive Sleep Apnea Syndrome, run by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- fixed continuous positive airway pressure (CPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2007to Mar 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Obstructive sleep apnea syndrome deserving CPAP treatment
Who cannot join
- current pharmacological treatment
Trial locations and contacts
1 site in 1 country.
Italy1 site
National Research Council - Institute of Biomedicine and Molecular Immunology (CNR - IBIM)
Palermo, 90146
About this study
Official title: 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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- Automatic (variable, automatically controlled) pressure CPAP, fixed continuous positive airway pressure (CPAP)
- Keywords
- OSAS, blood pressure, sympathetic nervous system, treatment, CPAP
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatic (variable, automatically controlled) pressure CPAPDevice
Also called Automatic CPAP "SOMNOsmart2", Weinmann, Hamburg Germany
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.
fixed continuous positive airway pressure (CPAP)Device
Also called fixed CPAP, constant level CPAP
CPAP at a constant level, whose efficacy on respiratory disorders has been determined by nocturnal titration.
Home nocturnal usage. Two-month treatment.
| Study group | Role | What they receive |
|---|---|---|
| fixed CPAP | Active comparator | Not described Receives: Device: fixed continuous positive airway pressure (CPAP) |
| Auto-CPAP | Experimental | Auto-CPAP Weinmann "Somnosmart2" Receives: Device: Automatic (variable, automatically controlled) pressure CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure and urinary catecholamines after conventional or auto-CPAP
Measured: 2 months
Secondary outcomes (1)
Relationship between catecholamines / blood pressure changes and compliance to treatment
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startMar 2007
- Primary completionDec 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
- Sponsor type
- Other government
- Collaborators
- Weinmann Geräte für Medizin GmbH + Co. KG
- Investigators
- Oreste Marrone, MD, Principal investigator, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633711
- Sponsor's protocol ID
- CNR-IBIM-001
- Status last verified
- Apr 2010
- First submitted
- 4 Mar 2008
- Last updated
- 16 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17494789Bazzano 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.
PubMed 17548722Alajmi 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.
PubMed 17393240Haentjens 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.
PubMed 17452537Parati 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.
PubMed 17652356Narkiewicz 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.
PubMed 12609010
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Effects of Chronic Treatment of OSAS by CPAP and SOMNOsmart2 on Norepinephrine and Blood Pressure
- ClinicalTrials.gov ID
- NCT00633711
- Acronym / sponsor ID
- CNR-IBIM-001
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- OSAS, blood pressure, sympathetic nervous system, treatment, CPAP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, ItalyOther government
- Collaborators
- Weinmann Geräte für Medizin GmbH + Co. KG
- Study start
- Mar 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 12 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fixed CPAP | Active comparator | Device: fixed continuous positive airway pressure (CPAP) |
| Auto-CPAP | Experimental | Device: Automatic (variable, automatically controlled) pressure CPAPAuto-CPAP Weinmann "Somnosmart2" |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Obstructive sleep apnea syndrome deserving CPAP treatment
Key exclusion criteria (1 listed)
- current pharmacological treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automatic (variable, automatically controlled) pressure CPAPAlso: Automatic CPAP "SOMNOsmart2", Weinmann, Hamburg GermanyCPAP 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 | Auto-CPAP |
| fixed continuous positive airway pressure (CPAP)Also: fixed CPAP, constant level CPAPCPAP at a constant level, whose efficacy on respiratory disorders has been determined by nocturnal titration. Home nocturnal usage. Two-month treatment. | Device | fixed CPAP |
Primary outcome
Blood pressure and urinary catecholamines after conventional or auto-CPAP
Time frame: 2 months
1 secondary outcome
Relationship between catecholamines / blood pressure changes and compliance to treatment
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2011.
- Background: PubMed 17494789Patruno 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.
- Background: PubMed 17548722Bazzano 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.
- Background: PubMed 17393240Alajmi 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.
- Background: PubMed 17452537Haentjens 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.
- Background: PubMed 17652356Parati 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.
- Background: PubMed 12609010Narkiewicz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oreste Marrone, MD principal investigator
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fixed continuous positive airway pressure (CPAP) in people with Obstructive Sleep Apnea Syndrome, run by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure and urinary catecholamines after conventional or auto-CPAP (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00633711, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2011.