Obstructive Sleep ApneaNCT01780207
Impact Of Closure Of Patent Foramen Ovale On Apnoea-Hypopnoea-Index, Nocturnal Hypoxemia And Systemic Vascular Function In Patients With Obstructive Sleep Apnoea
A study testing PFO Closure in people with Obstructive Sleep Apnea, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The purpose of this study in patients with obstructive sleep apnoea (OSA) and concomitant patent foramen ovale (PFO) is to assess the impact of percutaneous PFO closure on nocturnal hypoxemia and apnea/hypopnea, pulmonary and systemic artery pressure, endothelial function and arterial stiffness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- PFO Closure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteSwitzerland
- Study dates
- Start not givento May 2014
- Phase
- Interventional
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Patients with newly diagnosed moderate to severe OSA
- Age > 17 years
- Written informed consent for study participation.
Who cannot join
- Patients with other pulmonary disease associated with oxygen desaturation (other than obesity-associated pulmonary restriction)
- Patients with central sleep apnea syndrome
- Patients with other causes of pulmonary hypertension
- Intracardiac shunt other than via PFO
- Severe valvular heart disease
- Abnormal left ventricular (LV) systolic function (ejection fraction <50%)
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- Obesity with BMI > 40
- Contraindication to TOE
- Severe pulmonary arterial hypertension (mean pulmonary artery pressure > 45 mmHg)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study in patients with obstructive sleep apnoea (OSA) and concomitant patent foramen ovale (PFO) is to assess the impact of percutaneous PFO closure on nocturnal hypoxemia and apnea/hypopnea, pulmonary and systemic artery pressure, endothelial function and arterial stiffness.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- PFO Closure
- 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.
PFO ClosureDevice
| Study group | Role | What they receive |
|---|---|---|
| OSA without PFO | No intervention | Not described |
| OSA with PFO | Other | PFO closure Receives: Device: PFO Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index (AHI), apnea index (changes from baseline to follow-up)
Measured: 0, 3 months
Secondary outcomes (1)
Systemic vascular assessment
Measured: 0, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Primary completionMay 2014
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 Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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 N/A
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Seiler, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780207
- Sponsor's protocol ID
- 066/10
- Status last verified
- Dec 2014
- First submitted
- 29 Jan 2013
- Last updated
- 30 Dec 2014
- Results posted
- No
Publications
Rimoldi SF, Ott S, Rexhaj E, de Marchi SF, Allemann Y, Gugger M, Scherrer U, Seiler C. Patent Foramen Ovale Closure in Obstructive Sleep Apnea Improves Blood Pressure and Cardiovascular Function. Hypertension. 2015 Nov;66(5):1050-7. doi: 10.1161/HYPERTENSIONAHA.115.06303. Epub 2015 Sep 21.
PubMed 26418025
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Of Closure Of Patent Foramen Ovale On Apnoea-Hypopnoea-Index, Nocturnal Hypoxemia And Systemic Vascular Function In Patients With Obstructive Sleep Apnoea
- ClinicalTrials.gov ID
- NCT01780207
- Acronym / sponsor ID
- 066/10
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Primary completion
- May 2014 (actual)
- First posted
- 30 Jan 2013 (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 purpose of this study in patients with obstructive sleep apnoea (OSA) and concomitant patent foramen ovale (PFO) is to assess the impact of percutaneous PFO closure on nocturnal hypoxemia and apnea/hypopnea, pulmonary and systemic artery pressure, endothelial function and arterial stiffness.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSA without PFO | No intervention | – |
| OSA with PFO | Other | Device: PFO ClosurePFO closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with newly diagnosed moderate to severe OSA
- Age > 17 years
- Written informed consent for study participation.
Key exclusion criteria (9 listed)
- Patients with other pulmonary disease associated with oxygen desaturation (other than obesity-associated pulmonary restriction)
- Patients with central sleep apnea syndrome
- Patients with other causes of pulmonary hypertension
- Intracardiac shunt other than via PFO
- Severe valvular heart disease
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 |
|---|---|---|
| PFO Closure | Device | OSA with PFO |
Primary outcome
Apnea Hypopnea Index (AHI), apnea index (changes from baseline to follow-up)
Time frame: 0, 3 months
1 secondary outcome
Systemic vascular assessment
Time frame: 0, 3 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 30 Dec 2014.
- Derived from this study: PubMed 26418025Rimoldi SF, Ott S, Rexhaj E, de Marchi SF, Allemann Y, Gugger M, Scherrer U, Seiler C. Patent Foramen Ovale Closure in Obstructive Sleep Apnea Improves Blood Pressure and Cardiovascular Function. Hypertension. 2015 Nov;66(5):1050-7. doi: 10.1161/HYPERTENSIONAHA.115.06303. Epub 2015 Sep 21.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PFO Closure in people with Obstructive Sleep Apnea, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 3 inclusion and 9 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 30 Dec 2014. 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 Switzerland. 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.
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?
Apnea Hypopnea Index (AHI), apnea index (changes from baseline to follow-up) (time frame: 0, 3 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 NCT01780207, 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 30 Dec 2014.