Obstructive Sleep ApneaNCT06113562
Close Obstructive Sleep Apnea (OSA) Trial
A study testing PFO closure in people with Obstructive Sleep Apnea and Patent Foramen Ovale, run by University of Miami.
Trial summary
The aim of this study is to evaluate the benefits of patent foramen ovale (PFO) closure on patients with obstructive sleep apnea (OSA) and persistent hypoxia despite optimal therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea, Patent Foramen Ovale
- What is being tested?
- PFO closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 11 Feb 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals diagnosed with severe OSA, defined as an apnea-hypopnea index (AHI) greater than 30, associated with nocturnal saturation below 90%, as determined by a sleep medicine specialist using polysomnography.
- Individuals need to have a patent foramen ovale documented by echocardiography.
Who cannot join
- Individuals unable to take aspirin, clopidogrel, and/or ticagrelor.
- Pregnant individuals or those who become pregnant during the course of the study will be automatically withdrawn.
About this study
Official title: Patent Foramen Ovale Closure on Newly Diagnosed Patients With Obstructive Sleep Apnea and Refractory Hypoxia: A Pilot Study
The aim of this study is to evaluate the benefits of patent foramen ovale (PFO) closure on patients with obstructive sleep apnea (OSA) and persistent hypoxia despite optimal therapy.
- Conditions
- Obstructive Sleep Apnea, Patent Foramen Ovale
- Being tested
- PFO closure
- Medical subject headings
- Sleep Apnea, Obstructive, Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFO closureProcedure or surgery
The participants will receive a onetime closure of a small hole in heart. The procedure usually takes up to an hour. The procedure is done with local anesthesia and conscious sedation. A catheter is inserted into a vein in upper thigh and threaded to heart to deploy the closure device. Either Gore septal occluder or Amplatzer PFO occluder
| Study group | Role | What they receive |
|---|---|---|
| Persistent hypoxemia after Obstructive sleep apnea group | Experimental | Participants will receive Patent Foramen Ovale (PFO) closure and followed until repeat sleep apnea testing up to 6 months. Receives: Procedure: PFO closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in the apnea hypoxia index
The Apnea hypopnea index that ranges from:
0 to 5 is normal 5 to15 is mild 15 to 30 is moderate greater than 30 is severe.
Measured: baseline and then up to 3 months after the study
change in mean nocturnal oxygen saturation
Oxygen saturation will be measured in percentage. Ranges from 0 to 100 percent. The higher the percent the higher the oxygen saturation.
Measured: baseline and then up to 3 months after the study
change in duration of nocturnal oxygen desaturation duration.
Will be measured in seconds.
Measured: baseline and then up to 3 months after the study
Secondary outcomes (5)
change in quality of life as measured by the patient global impression of change scale.
Change Scale: Adapted Patient Clinical Global Impression of Improvement (CGI-I) scale rated by the patient is a 7-point scale of improvement from 'very much improved' to 'very much worse'. 'Very much improved' means a better outcome.
Measured: baseline and then up to 3 months after the study
change in quality of sleep as measured by the Epworth Sleepiness Scale
Epworth Sleepiness Scale: The Epworth Sleepiness Scale is widely used in the field of sleep medicine as a subjective measure of a patient's sleepiness. The test is a list of eight situations in which you rate your tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing.
Measured: baseline and then up to 3 months after the study
Change in physical activity as measured by Godin Leisure time physical activity questionnaire.
Self-reported leisure time physical activity as assessed by the Godin Leisure time physical activity questionnaire in all participants. Score range from 0 upwards, with higher scores indicating more leisure time physical activity.
Measured: baseline and then up to 3 months after the study
change in fatigue as measured by the Fatigue Severity Scale.
Each item is scored between 1 and 7 (1 = strongly disagree, 7 = totally agree) in the scale consisting of 9 items that can be applied by individuals in a simple way. The total score range of the scale is 9-63. The total score is calculated by taking the average of 9 items. Accordingly, the lowest average score to be obtained is 1, and the highest average score is 7. The cut-off value was set at 4 and above to diagnose pathological fatigue. The lower the total score, the less fatigue.
Measured: baseline and then up to 3 months after the study
changes in functional independence measure
The Functional independence measure (FIM) is an 18-item instrument comprising 13 motor items and 5 cognitive items, with each item graded on a 7-point ordinal scale (1 denotes complete dependence and 7 denotes complete independence), including the ability to perform activities of daily living (ADLs) across 6 areas (self-care, sphincter control, transfers, locomotion, communication, and social cognition). Total admission FIM (Ta-FIM) scores, total discharge FIM (Td-FIM) scores (18 - 126), motor FIM (m-FIM) sub-scores (13 - 91) and cognitive FIM (c-FIM) sub-scores (5 - 35), were tabulated.
Measured: baseline and then up to 3 months after the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Feb 2025
- Primary completion11 Feb 2025
- Study completion11 Feb 2025
Why it stopped: Withdrawn (Not able to enroll patients.)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo De Marchena, University of Miami
- Investigators
- Eduardo de Marchena, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113562
- Sponsor's protocol ID
- 20181090
- Status last verified
- Feb 2025
- First submitted
- 27 Oct 2023
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patent Foramen Ovale Closure on Newly Diagnosed Patients With Obstructive Sleep Apnea and Refractory Hypoxia: A Pilot Study
- ClinicalTrials.gov ID
- NCT06113562
- Acronym / sponsor ID
- 20181090
- Conditions
- Obstructive Sleep Apnea, Patent Foramen Ovale
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn (Not able to enroll patients.)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 11 Feb 2025 (actual)
- Study completion
- 11 Feb 2025 (actual)
- First posted
- 2 Nov 2023 (actual)
- 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 aim of this study is to evaluate the benefits of patent foramen ovale (PFO) closure on patients with obstructive sleep apnea (OSA) and persistent hypoxia despite optimal therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persistent hypoxemia after Obstructive sleep apnea group | Experimental | Procedure: PFO closureParticipants will receive Patent Foramen Ovale (PFO) closure and followed until repeat sleep apnea testing up to 6 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals diagnosed with severe OSA, defined as an apnea-hypopnea index (AHI) greater than 30, associated with nocturnal saturation below 90%, as determined by a sleep medicine specialist using polysomnography.
- Individuals need to have a patent foramen ovale documented by echocardiography.
Key exclusion criteria (2 listed)
- Individuals unable to take aspirin, clopidogrel, and/or ticagrelor.
- Pregnant individuals or those who become pregnant during the course of the study will be automatically withdrawn.
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 closureThe participants will receive a onetime closure of a small hole in heart. The procedure usually takes up to an hour. The procedure is done with local anesthesia and conscious sedation. A catheter is inserted into a vein in upper thigh and threaded to heart to deploy the closure device. Either Gore septal occluder or Amplatzer PFO occluder | Procedure or surgery | Persistent hypoxemia after Obstructive sleep apnea group |
Primary outcome
changes in the apnea hypoxia index
Time frame: baseline and then up to 3 months after the study
The Apnea hypopnea index that ranges from: 0 to 5 is normal 5 to15 is mild 15 to 30 is moderate greater than 30 is severe.
change in mean nocturnal oxygen saturation
Time frame: baseline and then up to 3 months after the study
Oxygen saturation will be measured in percentage. Ranges from 0 to 100 percent. The higher the percent the higher the oxygen saturation.
change in duration of nocturnal oxygen desaturation duration.
Time frame: baseline and then up to 3 months after the study
Will be measured in seconds.
5 secondary outcomes
change in quality of life as measured by the patient global impression of change scale.
Time frame: baseline and then up to 3 months after the study
change in quality of sleep as measured by the Epworth Sleepiness Scale
Time frame: baseline and then up to 3 months after the study
Change in physical activity as measured by Godin Leisure time physical activity questionnaire.
Time frame: baseline and then up to 3 months after the study
change in fatigue as measured by the Fatigue Severity Scale.
Time frame: baseline and then up to 3 months after the study
changes in functional independence measure
Time frame: baseline and then up to 3 months after the study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Eduardo de Marchena, MD principal investigator
University of Miami
Questions about this trial
What is this clinical trial studying?
A study testing PFO closure in people with Obstructive Sleep Apnea and Patent Foramen Ovale, run by University of Miami.
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 2 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: withdrawn, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
changes in the apnea hypoxia index (time frame: baseline and then up to 3 months after the study). 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?
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 20 Mar 2025.