Patent Foramen OvalePCOSA-1NCT02771561
PFO Closure for Obstructive Sleep Apnoea
A study testing Patent Foramen Ovale Closure in people with Patent Foramen Ovale and Obstructive Sleep Apnea, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Obstructive sleep apnoea (OSA) is a condition which involves episodes of interrupted breathing during sleep due to repetitive narrowing or collapse of the throat. These episodes are usually associated with a drop in blood oxygen levels and brief awakenings, which disrupt the sleep of those affected and can lead to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patent Foramen Ovale, Obstructive Sleep Apnea
- What is being tested?
- Patent Foramen Ovale Closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2013to Dec 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and older
- Diagnosis of obstructive sleep apnoea-hypopnoea syndrome (OSAHS)
- Epworth Sleepiness Scale score of 11 or greater
- Oxygen Desaturation Index of 20 or greater (and/or oxygen desaturation index/apnoea-hypopnoea index greater than 0.67)
- Naive to Continuous Positive Airway Pressure (CPAP) treatment, or CPAP intolerant (defined at any review as: CPAP use less than 4 hours per night and unable to tolerate/receive no benefit, or at clinical discretion), or poor CPAP responders (defined at any review as: failure to improve Epworth Sleepiness Scale score by more than 4 points from Epworth Sleepiness Scale score at diagnostic visit plus persistent symptoms suggesting poorly controlled OSAHS and/or a prior failure to tolerate CPAP therapy)
- Moderate to large Patent Foramen Ovale (PFO) as seen on a transthoracic echocardiogram bubble study
- CPAP naive patients with moderate-large PFO will start CPAP treatment during the study, but outcomes will be assessed at baseline (before starting CPAP treatment) and at six months post PFO closure (after one week of CPAP abstinence).
Who cannot join
- Coexistent significant respiratory disease (FEV1 <50% predicted)
- Weight >180kg (maximum weight allowance for echocardiogram table)
- Known or suspected pregnancy
- Other cardiac disease (valve disease, known cardiomyopathy, left ventricular failure, known congenital heart disease)
- Previous atrial septal closure device
- Inability to give informed consent or comply with the protocol
- Anatomically unsuitable for percutaneous PFO closure with Gore™ septal occluder device.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Papworth Hospital NHS Foundation Trust
Papworth Everard, Cambridgeshire, CB23 3RE
Stephanie Clutterbuck, PhD, 01480364169, stephanie.clutterbuck@nhs.net
Victoria Stoneman, PhD, 01480364823, victoria.stoneman@nhs.net
About this study
Official title: PFO Closure for Obstructive Sleep Apnoea-1 Study
Obstructive sleep apnoea (OSA) is a condition which involves episodes of interrupted breathing during sleep due to repetitive narrowing or collapse of the throat. These episodes are usually associated with a drop in blood oxygen levels and brief awakenings, which disrupt the sleep of those affected and can lead to daytime sleepiness. OSA is associated with an increased risk of heart disease and stroke.
In some individuals, the low oxygen levels in the blood can be made worse by also having a small hole in the heart, called a patent foramen ovale (PFO). This hole is present at birth in everyone, but in some people (about 30% of the normal population) it fails to close. Usually a PFO does not cause any medical problems. However, it may be recommended to have a PFO closed by key-hole surgery if someone suffers a stroke, severe migraine or if they are professional divers. There is a higher incidence of PFO in patients with OSA (25-50%) compared to the wider population and this may account for some of the observed increased risk of heart disease and stroke in patients with OSA.
This study will assess the number of patients with OSA who also have a PFO, and whether closing the PFO can improve the symptoms of OSA (e.g. sleepiness, exercise capacity and general well-being), thereby enabling the patient to not be reliant on treatment for OSA. If the study shows that closing the PFO is beneficial then the investigators will assess in a larger study if this treatment can also reduce heart disease and strokes.
Read the detailed description
Under normal conditions an interatrial communication allows blood to shunt from left to right due to a higher pressure in the left atrium than the right atrium and a greater compliance of the right ventricle than the left ventricle. Right-to-left interatrial shunting (RLS) is usually associated with spontaneous or induced pulmonary hypertension. RLS may occur spontaneously during a release phase of a Valsalva manoeuvres that transiently generates a right to left pressure gradient across the interatrial septum or rarely due to a condition termed platypnea-orthodeoxia. The latter is characterized by dyspnoea and deoxygenation accompanying a change to a sitting or standing from a recumbent position. Platypnea-orthodeoxia is thought to be due to a combination of an interatrial communication and an anatomical variant e.g. a persistent Eustachian valve and/or stretching and distortion of atrial septum allowing more streaming of venous blood from inferior vena cava through the defect when in the upright position. The recommended treatment of platypnea-orthodeoxia is percutaneous closure of patent foramen ovale (PFO).
Obstructive Sleep Apnoea - Hypopnoea Syndrome (OSAHS) is characterised by repetitive upper airway obstruction during sleep causing apnoea (cessation of breathing) and oxygen desaturation. It is a significant health burden on the National Health Service (NHS) and society, affecting approximately 4% middle aged men and 2% middle-aged women. The risk of OSAHS rises with increasing body weight, active smoking and age. OSAHS is set to reach epidemic proportions as the Western population ages and the incidence of obesity rises. About 1% of men in the United Kingdom (UK) have severe OSAHS with an apnoea-hypopnoea index (AHI; the average number of episodes of apnoeas and hypopnoeas per hour of sleep) of >20 and oxygen desaturation index (ODI; the number of desaturation episodes defined as ≥4% drop in oxygen saturations per hour during sleep) of >20, measured by nocturnal oximetry and respiratory polygraphy (intermediate sleep study or Embletta™). Patients with untreated severe OSAHS have a higher incidence of fatal (OR 2.87) and non-fatal (OR 3.17) cardiovascular events compared to age and sex matched controls. The degree of oxygen desaturation inversely correlates with survival and the link is thought to be multifactorial; raised blood viscosity due to increased haematocrit, sympathetic activation leading to arrhythmias and systemic hypertension are thought to be important. In a Cox model a 1% decrease in average nocturnal oxygen saturation (SaO2) was associated with a 33% increase in the incident risk of fatal and nonfatal cardiovascular events. Treatment with continuous positive airways pressure (CPAP) ventilation at night reduces symptoms (snoring, mood, day time sleepiness and headache) and cardiovascular event rate, but it is poorly tolerated and refused by up to a fifth of patients. Improvement in ODI and sleepiness in OSAHS treated by CPAP is transient and when CPAP is discontinued, measurements return to baseline within 1 week.
PFO is found with a higher incidence in patients with OSAHS than controls (69% vs. 17%) and may exacerbate the oxygen desaturation in OSAHS during apnoeic/ hypopnoeic episodes observed in some patients. In OSAHS patients with greater ODI to AHI ratio (ODI/AHI>0.67), the prevalence of large PFO was nine out of 15 (60%) versus two out of 15 (13%) in those with ODI/AHI <0.33. OSAHS is believed to raise right heart pressures and increase RLS via the interatrial defect due to repeated nocturnal Valsalva and Muller manoeuvres. Prolonged oxygen desaturation may further exacerbate sleep apnoea by decreasing central respiratory drive. In selected populations of OSAHS patients, PFO closure may be beneficial. This has been reported in a number of case reports but has not been studied in a larger trial population.
Hypothesis:
RLS via a PFO in patients with severe OSAHS: ESS≥11 and ODI≥20 or ODI/AHI >0.67, is deleterious and closing the PFO will improve oxygen saturation, exercise tolerance, symptoms, quality of life and will reduce CPAP requirement and, ultimately, will reduce the incidence of fatal/ non-fatal cardiovascular events.
This study will assess the improvement of symptoms of OSA (e.g. sleepiness, exercise capacity and general well-being) following PFO closure. Improving symptoms will enable patients to not be reliant on treatment for OSA. If PFO closure is beneficial the investigator aims to assess the efficacy of treatment to reduce heart disease and strokes in a larger study.
- Conditions
- Patent Foramen Ovale, Obstructive Sleep Apnea
- Being tested
- Patent Foramen Ovale Closure
- Keywords
- Patent Foramen Ovale, Obstructive Sleep Apnea, Apnea-Hypopnea Index, Oxygen Desaturation Index, Epworth Sleepiness Scale, Quality of life, Continuous Positive Airway Pressure, Obstructive Sleep Apnea-Hypopnea Syndrome, Gore™ septal occluder device
- Medical subject headings
- Foramen Ovale, Patent, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patent Foramen Ovale ClosureProcedure or surgery
Transoesophageal guided percutaneous patent foramen ovale closure using Gore™ septal occluder device
| Study group | Role | What they receive |
|---|---|---|
| Patent Foramen Ovale Closure | Other | All eligible participants undergo a patent foramen ovale closure procedure Receives: Procedure: Patent Foramen Ovale Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Epworth Sleepiness Scale
Measured: Change from baseline Epworth Sleepiness Scale score at six months post Patent Foramen Ovale Closure
Change in Apnoea-Hypopnoea Index
Measured: Change from baseline Apnoea-Hypopnoea Index at six months post Patent Foramen Ovale Closure
Change in Oxygen Desaturation Index
Measured: Change from baseline Oxygen Desaturation Index at six months post Patent Foramen Ovale Closure
Change in Six Minute Walk Test
Measured: Change from baseline six minute walk test at six months post Patent Foramen Ovale Closure
Change in Sleep Apnea Quality of Life Index (SAQLI)
Measured: Change from baseline SAQLI at six months post Patent Foramen Ovale Closure
Change in Functional Outcomes of Sleep Questionnaire (FOSQ)
Measured: Change from baseline FOSQ at six months post Patent Foramen Ovale Closure
Change in Short Form (36) Health Survey (SF36)
Measured: Change from baseline SF36 at six months post Patent Foramen Ovale Closure
Secondary outcomes (2)
Change in Continuous Positive Airway Pressure (CPAP)
CPAP use = the hours of use per 24 hour period. This is recorded by the CPAP device.
Measured: Change from baseline CPAP use at six months post Patent Foramen Ovale Closure
Cardiovascular events (CV)
Incidence of fatal and non-fatal CV events
Measured: Six months post Patent Foramen Ovale Closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startApr 2013
- Primary completionApr 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Patent Foramen OvaleStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Stephen Hoole, BM BCh, Principal investigator, Papworth Hospital NHS Foundation TrustMichael Davies, MB BS, Principal investigator, Papworth Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771561
- Sponsor's protocol ID
- P01725
- Acronym
- PCOSA-1
- Status last verified
- May 2016
- First submitted
- 5 May 2016
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: We do not plan to make individual participant data available.
Publications
Agnoletti G, Iserin L, Lafont A, Sidi D, Desnos M. Obstructive sleep apnoea and patent foramen ovale: successful treatment of symptoms by percutaneous foramen ovale closure. J Interv Cardiol. 2005 Oct;18(5):393-5. doi: 10.1111/j.1540-8183.2005.00072.x.
PubMed 16202118Beelke M, Angeli S, Del Sette M, De Carli F, Canovaro P, Nobili L, Ferrillo F. Obstructive sleep apnea can be provocative for right-to-left shunting through a patent foramen ovale. Sleep. 2002 Dec;25(8):856-62.
PubMed 12489891Bradley TD, Martinez D, Rutherford R, Lue F, Grossman RF, Moldofsky H, Zamel N, Phillipson EA. Physiological determinants of nocturnal arterial oxygenation in patients with obstructive sleep apnea. J Appl Physiol (1985). 1985 Nov;59(5):1364-8. doi: 10.1152/jappl.1985.59.5.1364.
PubMed 4066566Engleman HM, Martin SE, Kingshott RN, Mackay TW, Deary IJ, Douglas NJ. Randomised placebo controlled trial of daytime function after continuous positive airway pressure (CPAP) therapy for the sleep apnoea/hypopnoea syndrome. Thorax. 1998 May;53(5):341-5. doi: 10.1136/thx.53.5.341.
PubMed 9708223Johansson MC, Eriksson P, Peker Y, Hedner J, Rastam L, Lindblad U. The influence of patent foramen ovale on oxygen desaturation in obstructive sleep apnoea. Eur Respir J. 2007 Jan;29(1):149-55. doi: 10.1183/09031936.00035906. Epub 2006 Sep 27.
PubMed 17005584La Rovere MT, Pinna GD, Hohnloser SH, Marcus FI, Mortara A, Nohara R, Bigger JT Jr, Camm AJ, Schwartz PJ; ATRAMI Investigators. Autonomic Tone and Reflexes After Myocardial Infarcton. Baroreflex sensitivity and heart rate variability in the identification of patients at risk for life-threatening arrhythmias: implications for clinical trials. Circulation. 2001 Apr 24;103(16):2072-7. doi: 10.1161/01.cir.103.16.2072.
PubMed 11319197Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7.
PubMed 15781100Shanoudy H, Soliman A, Raggi P, Liu JW, Russell DC, Jarmukli NF. Prevalence of patent foramen ovale and its contribution to hypoxemia in patients with obstructive sleep apnea. Chest. 1998 Jan;113(1):91-6. doi: 10.1378/chest.113.1.91.
PubMed 9440574Silver B, Greenbaum A, McCarthy S. Improvement in sleep apnea associated with closure of a patent foramen ovale. J Clin Sleep Med. 2007 Apr 15;3(3):295-6.
PubMed 17561600Smith ML, Niedermaier ON, Hardy SM, Decker MJ, Strohl KP. Role of hypoxemia in sleep apnea-induced sympathoexcitation. J Auton Nerv Syst. 1996 Jan 5;56(3):184-90. doi: 10.1016/0165-1838(95)00062-3.
PubMed 8847442van den Aardweg JG, Karemaker JM. Repetitive apneas induce periodic hypertension in normal subjects through hypoxia. J Appl Physiol (1985). 1992 Mar;72(3):821-7. doi: 10.1152/jappl.1992.72.3.821.
PubMed 1568978Young T, Palta M, Dempsey J, Peppard PE, Nieto FJ, Hla KM. Burden of sleep apnea: rationale, design, and major findings of the Wisconsin Sleep Cohort study. WMJ. 2009 Aug;108(5):246-9.
PubMed 19743755Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
PubMed 8464434Zoccali C, Mallamaci F, Tripepi G. Nocturnal hypoxemia predicts incident cardiovascular complications in dialysis patients. J Am Soc Nephrol. 2002 Mar;13(3):729-733. doi: 10.1681/ASN.V133729.
PubMed 11856778
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PFO Closure for Obstructive Sleep Apnoea-1 Study
- ClinicalTrials.gov ID
- NCT02771561
- Acronym / sponsor ID
- PCOSA-1 / P01725
- Conditions
- Patent Foramen Ovale, Obstructive Sleep Apnea
- Keywords
- Patent Foramen Ovale, Obstructive Sleep Apnea, Apnea-Hypopnea Index, Oxygen Desaturation Index, Epworth Sleepiness Scale, Quality of life, Continuous Positive Airway Pressure, Obstructive Sleep Apnea-Hypopnea Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Study start
- Apr 2013
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 13 May 2016 (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 apnoea (OSA) is a condition which involves episodes of interrupted breathing during sleep due to repetitive narrowing or collapse of the throat. These episodes are usually associated with a drop in blood oxygen levels and brief awakenings, which disrupt the sleep of those affected and can lead to daytime sleepiness. OSA is associated with an increased risk of heart disease and stroke.
In some individuals, the low oxygen levels in the blood can be made worse by also having a small hole in the heart, called a patent foramen ovale (PFO). This hole is present at birth in everyone, but in some people (about 30% of the normal population) it fails to close. Usually a PFO does not cause any medical problems. However, it may be recommended to have a PFO closed by key-hole surgery if someone suffers a stroke, severe migraine or if they are professional divers. There is a higher incidence of PFO in patients with OSA (25-50%) compared to the wider population and this may account for some of the observed increased risk of heart disease and stroke in patients with OSA.
This study will assess the number of patients with OSA who also have a PFO, and whether closing the PFO can improve the symptoms of OSA (e.g. sleepiness, exercise capacity and general well-being), thereby enabling the patient to not be reliant on treatment for OSA. If the study shows that closing the PFO is beneficial then the investigators will assess in a larger study if this treatment can also reduce heart disease and strokes.
Detailed description
Under normal conditions an interatrial communication allows blood to shunt from left to right due to a higher pressure in the left atrium than the right atrium and a greater compliance of the right ventricle than the left ventricle. Right-to-left interatrial shunting (RLS) is usually associated with spontaneous or induced pulmonary hypertension. RLS may occur spontaneously during a release phase of a Valsalva manoeuvres that transiently generates a right to left pressure gradient across the interatrial septum or rarely due to a condition termed platypnea-orthodeoxia. The latter is characterized by dyspnoea and deoxygenation accompanying a change to a sitting or standing from a recumbent position. Platypnea-orthodeoxia is thought to be due to a combination of an interatrial communication and an anatomical variant e.g. a persistent Eustachian valve and/or stretching and distortion of atrial septum allowing more streaming of venous blood from inferior vena cava through the defect when in the upright position. The recommended treatment of platypnea-orthodeoxia is percutaneous closure of patent foramen ovale (PFO).
Obstructive Sleep Apnoea - Hypopnoea Syndrome (OSAHS) is characterised by repetitive upper airway obstruction during sleep causing apnoea (cessation of breathing) and oxygen desaturation. It is a significant health burden on the National Health Service (NHS) and society, affecting approximately 4% middle aged men and 2% middle-aged women. The risk of OSAHS rises with increasing body weight, active smoking and age. OSAHS is set to reach epidemic proportions as the Western population ages and the incidence of obesity rises. About 1% of men in the United Kingdom (UK) have severe OSAHS with an apnoea-hypopnoea index (AHI; the average number of episodes of apnoeas and hypopnoeas per hour of sleep) of >20 and oxygen desaturation index (ODI; the number of desaturation episodes defined as ≥4% drop in oxygen saturations per hour during sleep) of >20, measured by nocturnal oximetry and respiratory polygraphy (intermediate sleep study or Embletta™). Patients with untreated severe OSAHS have a higher incidence of fatal (OR 2.87) and non-fatal (OR 3.17) cardiovascular events compared to age and sex matched controls. The degree of oxygen desaturation inversely correlates with survival and the link is thought to be multifactorial; raised blood viscosity due to increased haematocrit, sympathetic activation leading to arrhythmias and systemic hypertension are thought to be important. In a Cox model a 1% decrease in average nocturnal oxygen saturation (SaO2) was associated with a 33% increase in the incident risk of fatal and nonfatal cardiovascular events. Treatment with continuous positive airways pressure (CPAP) ventilation at night reduces symptoms (snoring, mood, day time sleepiness and headache) and cardiovascular event rate, but it is poorly tolerated and refused by up to a fifth of patients. Improvement in ODI and sleepiness in OSAHS treated by CPAP is transient and when CPAP is discontinued, measurements return to baseline within 1 week.
PFO is found with a higher incidence in patients with OSAHS than controls (69% vs. 17%) and may exacerbate the oxygen desaturation in OSAHS during apnoeic/ hypopnoeic episodes observed in some patients. In OSAHS patients with greater ODI to AHI ratio (ODI/AHI>0.67), the prevalence of large PFO was nine out of 15 (60%) versus two out of 15 (13%) in those with ODI/AHI <0.33. OSAHS is believed to raise right heart pressures and increase RLS via the interatrial defect due to repeated nocturnal Valsalva and Muller manoeuvres. Prolonged oxygen desaturation may further exacerbate sleep apnoea by decreasing central respiratory drive. In selected populations of OSAHS patients, PFO closure may be beneficial. This has been reported in a number of case reports but has not been studied in a larger trial population.
Hypothesis:
RLS via a PFO in patients with severe OSAHS: ESS≥11 and ODI≥20 or ODI/AHI >0.67, is deleterious and closing the PFO will improve oxygen saturation, exercise tolerance, symptoms, quality of life and will reduce CPAP requirement and, ultimately, will reduce the incidence of fatal/ non-fatal cardiovascular events.
This study will assess the improvement of symptoms of OSA (e.g. sleepiness, exercise capacity and general well-being) following PFO closure. Improving symptoms will enable patients to not be reliant on treatment for OSA. If PFO closure is beneficial the investigator aims to assess the efficacy of treatment to reduce heart disease and strokes in a larger study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patent Foramen Ovale Closure | Other | Procedure: Patent Foramen Ovale ClosureAll eligible participants undergo a patent foramen ovale closure procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years and older
- Diagnosis of obstructive sleep apnoea-hypopnoea syndrome (OSAHS)
- Epworth Sleepiness Scale score of 11 or greater
- Oxygen Desaturation Index of 20 or greater (and/or oxygen desaturation index/apnoea-hypopnoea index greater than 0.67)
- Naive to Continuous Positive Airway Pressure (CPAP) treatment, or CPAP intolerant (defined at any review as: CPAP use less than 4 hours per night and unable to tolerate/receive no benefit, or at clinical discretion), or poor CPAP responders (defined at any review as: failure to improve Epworth Sleepiness Scale score by more than 4 points from Epworth Sleepiness Scale score at diagnostic visit plus persistent symptoms suggesting poorly controlled OSAHS and/or a prior failure to tolerate CPAP therapy)
Key exclusion criteria (7 listed)
- Coexistent significant respiratory disease (FEV1 <50% predicted)
- Weight >180kg (maximum weight allowance for echocardiogram table)
- Known or suspected pregnancy
- Other cardiac disease (valve disease, known cardiomyopathy, left ventricular failure, known congenital heart disease)
- Previous atrial septal closure device
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 |
|---|---|---|
| Patent Foramen Ovale ClosureTransoesophageal guided percutaneous patent foramen ovale closure using Gore™ septal occluder device | Procedure or surgery | Patent Foramen Ovale Closure |
Primary outcome
Change in Epworth Sleepiness Scale
Time frame: Change from baseline Epworth Sleepiness Scale score at six months post Patent Foramen Ovale Closure
Change in Apnoea-Hypopnoea Index
Time frame: Change from baseline Apnoea-Hypopnoea Index at six months post Patent Foramen Ovale Closure
Change in Oxygen Desaturation Index
Time frame: Change from baseline Oxygen Desaturation Index at six months post Patent Foramen Ovale Closure
Change in Six Minute Walk Test
Time frame: Change from baseline six minute walk test at six months post Patent Foramen Ovale Closure
Change in Sleep Apnea Quality of Life Index (SAQLI)
Time frame: Change from baseline SAQLI at six months post Patent Foramen Ovale Closure
Change in Functional Outcomes of Sleep Questionnaire (FOSQ)
Time frame: Change from baseline FOSQ at six months post Patent Foramen Ovale Closure
Change in Short Form (36) Health Survey (SF36)
Time frame: Change from baseline SF36 at six months post Patent Foramen Ovale Closure
2 secondary outcomes
Change in Continuous Positive Airway Pressure (CPAP)
Time frame: Change from baseline CPAP use at six months post Patent Foramen Ovale Closure
Cardiovascular events (CV)
Time frame: Six months post Patent Foramen Ovale Closure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Background: PubMed 16202118Agnoletti G, Iserin L, Lafont A, Sidi D, Desnos M. Obstructive sleep apnoea and patent foramen ovale: successful treatment of symptoms by percutaneous foramen ovale closure. J Interv Cardiol. 2005 Oct;18(5):393-5. doi: 10.1111/j.1540-8183.2005.00072.x.
- Background: PubMed 12489891Beelke M, Angeli S, Del Sette M, De Carli F, Canovaro P, Nobili L, Ferrillo F. Obstructive sleep apnea can be provocative for right-to-left shunting through a patent foramen ovale. Sleep. 2002 Dec;25(8):856-62.
- Background: PubMed 4066566Bradley TD, Martinez D, Rutherford R, Lue F, Grossman RF, Moldofsky H, Zamel N, Phillipson EA. Physiological determinants of nocturnal arterial oxygenation in patients with obstructive sleep apnea. J Appl Physiol (1985). 1985 Nov;59(5):1364-8. doi: 10.1152/jappl.1985.59.5.1364.
- Background: PubMed 9708223Engleman HM, Martin SE, Kingshott RN, Mackay TW, Deary IJ, Douglas NJ. Randomised placebo controlled trial of daytime function after continuous positive airway pressure (CPAP) therapy for the sleep apnoea/hypopnoea syndrome. Thorax. 1998 May;53(5):341-5. doi: 10.1136/thx.53.5.341.
- Background: PubMed 17005584Johansson MC, Eriksson P, Peker Y, Hedner J, Rastam L, Lindblad U. The influence of patent foramen ovale on oxygen desaturation in obstructive sleep apnoea. Eur Respir J. 2007 Jan;29(1):149-55. doi: 10.1183/09031936.00035906. Epub 2006 Sep 27.
- Background: PubMed 11319197La Rovere MT, Pinna GD, Hohnloser SH, Marcus FI, Mortara A, Nohara R, Bigger JT Jr, Camm AJ, Schwartz PJ; ATRAMI Investigators. Autonomic Tone and Reflexes After Myocardial Infarcton. Baroreflex sensitivity and heart rate variability in the identification of patients at risk for life-threatening arrhythmias: implications for clinical trials. Circulation. 2001 Apr 24;103(16):2072-7. doi: 10.1161/01.cir.103.16.2072.
- Background: PubMed 15781100Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7.
- Background: PubMed 9440574Shanoudy H, Soliman A, Raggi P, Liu JW, Russell DC, Jarmukli NF. Prevalence of patent foramen ovale and its contribution to hypoxemia in patients with obstructive sleep apnea. Chest. 1998 Jan;113(1):91-6. doi: 10.1378/chest.113.1.91.
- Background: PubMed 17561600Silver B, Greenbaum A, McCarthy S. Improvement in sleep apnea associated with closure of a patent foramen ovale. J Clin Sleep Med. 2007 Apr 15;3(3):295-6.
- Background: PubMed 8847442Smith ML, Niedermaier ON, Hardy SM, Decker MJ, Strohl KP. Role of hypoxemia in sleep apnea-induced sympathoexcitation. J Auton Nerv Syst. 1996 Jan 5;56(3):184-90. doi: 10.1016/0165-1838(95)00062-3.
- Background: PubMed 1568978van den Aardweg JG, Karemaker JM. Repetitive apneas induce periodic hypertension in normal subjects through hypoxia. J Appl Physiol (1985). 1992 Mar;72(3):821-7. doi: 10.1152/jappl.1992.72.3.821.
- Background: PubMed 19743755Young T, Palta M, Dempsey J, Peppard PE, Nieto FJ, Hla KM. Burden of sleep apnea: rationale, design, and major findings of the Wisconsin Sleep Cohort study. WMJ. 2009 Aug;108(5):246-9.
- Individual participant dataSharing planned: No. We do not plan to make individual participant data available.
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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.
Stephen Hoole, BM BCh principal investigator
Papworth Hospital NHS Foundation Trust
Michael Davies, MB BS principal investigator
Papworth Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patent Foramen Ovale Closure in people with Patent Foramen Ovale and Obstructive Sleep Apnea, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
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 7 inclusion and 7 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 13 May 2016. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Clutterbuck, PhD (01480364169, stephanie.clutterbuck@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Epworth Sleepiness Scale (time frame: Change from baseline Epworth Sleepiness Scale score at six months post Patent Foramen Ovale Closure). The study lists 7 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 NCT02771561, which also lists 14 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 13 May 2016.