UnknownNot Applicable

PFO Closure for Obstructive Sleep Apnoea

United Kingdom30 participantsStarted 2013-04

Plain-language 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 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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). Exclusion Criteria: * 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 i…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Epworth Sleepiness Scale

Timeframe: Change from baseline Epworth Sleepiness Scale score at six months post Patent Foramen Ovale Closure

Change in Apnoea-Hypopnoea Index

Timeframe: Change from baseline Apnoea-Hypopnoea Index at six months post Patent Foramen Ovale Closure

Change in Oxygen Desaturation Index

Timeframe: Change from baseline Oxygen Desaturation Index at six months post Patent Foramen Ovale Closure

Change in Six Minute Walk Test

Timeframe: Change from baseline six minute walk test at six months post Patent Foramen Ovale Closure

Change in Sleep Apnea Quality of Life Index (SAQLI)

Timeframe: Change from baseline SAQLI at six months post Patent Foramen Ovale Closure

Change in Functional Outcomes of Sleep Questionnaire (FOSQ)

Timeframe: Change from baseline FOSQ at six months post Patent Foramen Ovale Closure

Trial details

NCT IDNCT02771561

SponsorPapworth Hospital NHS Foundation Trust

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2017-04

Contact for this trial

Stephanie Clutterbuck, PhD

01480364169 stephanie.clutterbuck@nhs.net

View on ClinicalTrials.gov More Patent Foramen Ovale trials