Sleep Apnea SyndromePhase 4NCT00517777
Continuous Positive Airway Pressure in Sleep Apnea Syndrome: Effects on Metabolic Syndrome and Cardiac Damage
A Phase 4 study testing continuous positive airway pressure ventilation and dietary and life style recommendations in people with Sleep Apnea Syndrome and Metabolic Syndrome, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial summary
To assess in moderate to severe Obstructive Sleep Apnea the effects of one year therapy with nighttime continuous positive airway pressure ventilation on the prevalence of metabolic syndrome and cardiovascular damage. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Sleep Apnea Syndrome, Metabolic Syndrome, Cardiac Remodelling
- What is being tested?
- continuous positive airway pressure ventilation and dietary and life style recommendations
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2007to Aug 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- moderate to severe sleep apnea syndrome
Who cannot join
- cardiovascular diseases (coronary artery disease, stroke, peripheral artery disease)
- thyroid diseases
- diabetes
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Insubria-Department of Clinical Medicine
Varese, 21100
anna maria grandi, MD, +39+332 278594, amgrandi@libero.it
andrea maria maresca, MD
About this study
Official title: Effects of the Continuous Positive Airway Pressure Ventilation on the Prevalence of the Metabolic Syndrome and Cardiac Morpho-Functional Characteristics in Sleep Apnea Syndrome
To assess in moderate to severe Obstructive Sleep Apnea the effects of one year therapy with nighttime continuous positive airway pressure ventilation on the prevalence of metabolic syndrome and cardiovascular damage.
- Conditions
- Sleep Apnea Syndrome, Metabolic Syndrome, Cardiac Remodelling, Continuous Positive Airway Pressure Ventilation
- Being tested
- continuous positive airway pressure ventilation, dietary and life style recommendations
- Keywords
- sleep apnea syndrome, metabolic syndrome, cardiac remodelling, continuous positive airway pressure ventilation
- Medical subject headings
- Sleep Apnea Syndromes, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous positive airway pressure ventilationDevice
nighttime
dietary and life style recommendationsBehavioural
dietary and life style recommendationsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | continuous positive airway pressure ventilation + dietary and life style recommendations Receives: Device: continuous positive airway pressure ventilation; Behavioral: dietary and life style recommendations |
| 2 | Active comparator | dietary and life style recommendations Receives: Behavioral: dietary and life style recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
metabolic syndrome
Measured: one year
left ventricular mass
Measured: one year
diastolic function
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2007 (estimated)
- Study startAug 2007
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Investigators
- anna maria grandi, MD, Principal investigator, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517777
- Sponsor's protocol ID
- 1113
- Status last verified
- Aug 2007
- First submitted
- 15 Aug 2007
- Last updated
- 17 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Grundy SM, Brewer HB Jr, Cleeman JI, Smith SC Jr, Lenfant C; American Heart Association; National Heart, Lung, and Blood Institute. Definition of metabolic syndrome: Report of the National Heart, Lung, and Blood Institute/American Heart Association conference on scientific issues related to definition. Circulation. 2004 Jan 27;109(3):433-8. doi: 10.1161/01.CIR.0000111245.75752.C6. No abstract available.
PubMed 14744958Cloward TV, Walker JM, Farney RJ, Anderson JL. Left ventricular hypertrophy is a common echocardiographic abnormality in severe obstructive sleep apnea and reverses with nasal continuous positive airway pressure. Chest. 2003 Aug;124(2):594-601. doi: 10.1378/chest.124.2.594.
PubMed 12907548Norman D, Loredo JS, Nelesen RA, Ancoli-Israel S, Mills PJ, Ziegler MG, Dimsdale JE. Effects of continuous positive airway pressure versus supplemental oxygen on 24-hour ambulatory blood pressure. Hypertension. 2006 May;47(5):840-5. doi: 10.1161/01.HYP.0000217128.41284.78. Epub 2006 Apr 3.
PubMed 16585412Shivalkar B, Van de Heyning C, Kerremans M, Rinkevich D, Verbraecken J, De Backer W, Vrints C. Obstructive sleep apnea syndrome: more insights on structural and functional cardiac alterations, and the effects of treatment with continuous positive airway pressure. J Am Coll Cardiol. 2006 Apr 4;47(7):1433-9. doi: 10.1016/j.jacc.2005.11.054. Epub 2006 Mar 15.
PubMed 16580533
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Continuous Positive Airway Pressure Ventilation on the Prevalence of the Metabolic Syndrome and Cardiac Morpho-Functional Characteristics in Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT00517777
- Acronym / sponsor ID
- 1113
- Conditions
- Sleep Apnea Syndrome, Metabolic Syndrome, Cardiac Remodelling, Continuous Positive Airway Pressure Ventilation
- Keywords
- sleep apnea syndrome, metabolic syndrome, cardiac remodelling, continuous positive airway pressure ventilation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- Aug 2007
- Study completion
- Aug 2010 (estimated)
- First posted
- 17 Aug 2007 (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.
To assess in moderate to severe Obstructive Sleep Apnea the effects of one year therapy with nighttime continuous positive airway pressure ventilation on the prevalence of metabolic syndrome and cardiovascular damage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: continuous positive airway pressure ventilation, Behavioral: dietary and life style recommendationscontinuous positive airway pressure ventilation + dietary and life style recommendations |
| 2 | Active comparator | Behavioral: dietary and life style recommendationsdietary and life style recommendations |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- moderate to severe sleep apnea syndrome
Key exclusion criteria (3 listed)
- cardiovascular diseases (coronary artery disease, stroke, peripheral artery disease)
- thyroid diseases
- diabetes
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 |
|---|---|---|
| continuous positive airway pressure ventilationnighttime | Device | 1 |
| dietary and life style recommendations | Behavioural | 2 |
| dietary and life style recommendations | Behavioural | 1 |
Primary outcome
metabolic syndrome
Time frame: one year
left ventricular mass
Time frame: one year
diastolic function
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2007.
- Background: PubMed 14744958Grundy SM, Brewer HB Jr, Cleeman JI, Smith SC Jr, Lenfant C; American Heart Association; National Heart, Lung, and Blood Institute. Definition of metabolic syndrome: Report of the National Heart, Lung, and Blood Institute/American Heart Association conference on scientific issues related to definition. Circulation. 2004 Jan 27;109(3):433-8. doi: 10.1161/01.CIR.0000111245.75752.C6. No abstract available.
- Background: PubMed 12907548Cloward TV, Walker JM, Farney RJ, Anderson JL. Left ventricular hypertrophy is a common echocardiographic abnormality in severe obstructive sleep apnea and reverses with nasal continuous positive airway pressure. Chest. 2003 Aug;124(2):594-601. doi: 10.1378/chest.124.2.594.
- Background: PubMed 16585412Norman D, Loredo JS, Nelesen RA, Ancoli-Israel S, Mills PJ, Ziegler MG, Dimsdale JE. Effects of continuous positive airway pressure versus supplemental oxygen on 24-hour ambulatory blood pressure. Hypertension. 2006 May;47(5):840-5. doi: 10.1161/01.HYP.0000217128.41284.78. Epub 2006 Apr 3.
- Background: PubMed 16580533Shivalkar B, Van de Heyning C, Kerremans M, Rinkevich D, Verbraecken J, De Backer W, Vrints C. Obstructive sleep apnea syndrome: more insights on structural and functional cardiac alterations, and the effects of treatment with continuous positive airway pressure. J Am Coll Cardiol. 2006 Apr 4;47(7):1433-9. doi: 10.1016/j.jacc.2005.11.054. Epub 2006 Mar 15.
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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.
anna maria grandi, MD principal investigator
Università degli Studi dell'Insubria
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 continuous positive airway pressure ventilation and dietary and life style recommendations in people with Sleep Apnea Syndrome and Metabolic Syndrome, run by Università degli Studi dell'Insubria 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 3 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: status not confirmed, as of the sponsor's last update on 17 Aug 2007. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
metabolic syndrome (time frame: one year). The study lists 3 primary outcomes in all. 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 NCT00517777, which also lists 4 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 17 Aug 2007.