Sleep ApneaPhase 4TREATOSA-MSNCT02295202
Impact of Obstructive Sleep Apnea Treatment in Patients With Metabolic Syndrome
A Phase 4 study testing CPAP (REMstar System One Plus - Philips Medical Systems) and Nasal strips in people with Sleep Apnea and Metabolic Syndrome, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Obstructive Sleep Apnea (OSA) is a common condition that may induce hemodynamic and metabolic dysregulation. However, it is not clear if OSA is a mere epiphenomenon or contributes to increase the morbidity associated with metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sleep Apnea, Metabolic Syndrome
- What is being tested?
- CPAP (REMstar System One Plus - Philips Medical Systems) and Nasal strips
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2015to Dec 2019
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metabolic Syndrome (ATP III)
- Moderate to severe OSA
Who cannot join
- Smokers
- Patients under chronic use of medications
- Neurological diseases
- Coronary artery disease
- Acute heart failure
- Chronic renal failure (GFR < 30 ml/min)
- Chronic obstructive pulmonary disease
- Mild OSA and patients with BMI over 40 kg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Obstructive Sleep Apnea Treatment in Patients With Metabolic Syndrome: A Randomized Study
Obstructive Sleep Apnea (OSA) is a common condition that may induce hemodynamic and metabolic dysregulation. However, it is not clear if OSA is a mere epiphenomenon or contributes to increase the morbidity associated with metabolic syndrome. This study was designed to evaluate the impact of OSA treatment with CPAP in consecutive patients with metabolic syndrome.
- Conditions
- Sleep Apnea, Metabolic Syndrome
- Being tested
- CPAP (REMstar System One Plus - Philips Medical Systems), Nasal strips
- 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.
CPAP (REMstar System One Plus - Philips Medical Systems)Device
Standard device for treating obstructive sleep apnea.
Nasal stripsDevice
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Experimental | CPAP: Continuous Positive Airway Pressure - Device used for treating OSA during sleep. Receives: Device: CPAP (REMstar System One Plus - Philips Medical Systems) |
| Placebo | Placebo comparator | Nasal Strips Receives: Device: Nasal strips |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reversibility of Metabolic Syndrome criteria
Measured: 6 months
Secondary outcomes (10)
Abdominal fat
Abdominal CT
Measured: 6 months
Hepatic steatosis
Abdominal CT
Measured: 6 months
carotid intima-media thickness
Carotid ultrasound
Measured: 6 months
endothelial function
Braquial artery ultrasound (flow mediated dilation, %)
Measured: 6 months
coronary atherosclerosis
Coronary CT
Measured: 6 months
Inflammatory markers
C-reactive protein
Measured: 6 months
Metabolomics
Metabolomic analysis (intended to be a sub-study)
Measured: 6 months
MicroRNAs
MicroRNAs analysis (intended to be a sub-study)
Measured: 6 months
Epicardic fat
Epicardic fat quantification by CT (intended to be a sub-study)
Measured: 6 months
Heart remodeling
Evaluated by Tranthoracic echocardiography (intended to be a sub-study)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startMar 2015
- Primary completionApr 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fleury
- Responsible party
- Principal investigator, Luciano F Drager, MD, PhD, University of Sao Paulo
- Investigators
- Luciano F Drager, MD, PhD, Principal investigator, Heart Institute (InCor), University of Sao Paulo Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295202
- Sponsor's protocol ID
- SDC 4075/14/055
- Acronym
- TREATOSA-MS
- Status last verified
- Jun 2020
- First submitted
- 12 Nov 2014
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Giampa SQC, Furlan SF, Freitas LS, Macedo TA, Lebkuchen A, Cardozo KHM, Carvalho VM, Martins FC, Azam IFB, Costa-Hong V, Lopes HF, Baptista ML, Rochitte CE, Bortolotto LA, Lorenzi-Filho G, Drager LF. Effects of CPAP on Metabolic Syndrome in Patients With OSA: A Randomized Trial. Chest. 2022 May;161(5):1370-1381. doi: 10.1016/j.chest.2021.12.669. Epub 2022 Jan 19.
PubMed 35063452
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Obstructive Sleep Apnea Treatment in Patients With Metabolic Syndrome: A Randomized Study
- ClinicalTrials.gov ID
- NCT02295202
- Acronym / sponsor ID
- TREATOSA-MS / SDC 4075/14/055
- Conditions
- Sleep Apnea, Metabolic Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fleury
- Study start
- Mar 2015
- Primary completion
- Apr 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 20 Nov 2014 (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.
Obstructive Sleep Apnea (OSA) is a common condition that may induce hemodynamic and metabolic dysregulation. However, it is not clear if OSA is a mere epiphenomenon or contributes to increase the morbidity associated with metabolic syndrome. This study was designed to evaluate the impact of OSA treatment with CPAP in consecutive patients with metabolic syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP | Experimental | Device: CPAP (REMstar System One Plus - Philips Medical Systems)CPAP: Continuous Positive Airway Pressure - Device used for treating OSA during sleep. |
| Placebo | Placebo comparator | Device: Nasal stripsNasal Strips |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Metabolic Syndrome (ATP III)
- Moderate to severe OSA
Key exclusion criteria (8 listed)
- Smokers
- Patients under chronic use of medications
- Neurological diseases
- Coronary artery disease
- Acute heart failure
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 |
|---|---|---|
| CPAP (REMstar System One Plus - Philips Medical Systems)Standard device for treating obstructive sleep apnea. | Device | CPAP |
| Nasal strips | Device | Placebo |
Primary outcome
Reversibility of Metabolic Syndrome criteria
Time frame: 6 months
10 secondary outcomes
Abdominal fat
Time frame: 6 months
Hepatic steatosis
Time frame: 6 months
carotid intima-media thickness
Time frame: 6 months
endothelial function
Time frame: 6 months
coronary atherosclerosis
Time frame: 6 months
Inflammatory markers
Time frame: 6 months
Metabolomics
Time frame: 6 months
MicroRNAs
Time frame: 6 months
Epicardic fat
Time frame: 6 months
Heart remodeling
Time frame: 6 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 18 Jun 2020.
- Derived from this study: PubMed 35063452Giampa SQC, Furlan SF, Freitas LS, Macedo TA, Lebkuchen A, Cardozo KHM, Carvalho VM, Martins FC, Azam IFB, Costa-Hong V, Lopes HF, Baptista ML, Rochitte CE, Bortolotto LA, Lorenzi-Filho G, Drager LF. Effects of CPAP on Metabolic Syndrome in Patients With OSA: A Randomized Trial. Chest. 2022 May;161(5):1370-1381. doi: 10.1016/j.chest.2021.12.669. Epub 2022 Jan 19.
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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.
Luciano F Drager, MD, PhD principal investigator
Heart Institute (InCor), University of Sao Paulo Medical School
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 CPAP (REMstar System One Plus - Philips Medical Systems) and Nasal strips in people with Sleep Apnea and Metabolic Syndrome, run by University of Sao Paulo at 1 site in Brazil.
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 2 inclusion and 8 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 18 Jun 2020. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Reversibility of Metabolic Syndrome criteria (time frame: 6 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 NCT02295202, which also lists 1 linked publication.
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 18 Jun 2020.