PFO Closure for Obstructive Sleep Apnoea (PCOSA-1)
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|ClinicalTrials.gov Identifier: NCT02771561|
Recruitment Status : Unknown
Verified May 2016 by Papworth Hospital NHS Foundation Trust.
Recruitment status was: Recruiting
First Posted : May 13, 2016
Last Update Posted : May 13, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Patent Foramen Ovale Obstructive Sleep Apnea||Procedure: Patent Foramen Ovale Closure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PFO Closure for Obstructive Sleep Apnoea-1 Study|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||December 2017|
Patent Foramen Ovale Closure
All eligible participants undergo a patent foramen ovale closure procedure
Procedure: Patent Foramen Ovale Closure
Transoesophageal guided percutaneous patent foramen ovale closure using Gore™ septal occluder device
- 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 ]
- Change in Continuous Positive Airway Pressure (CPAP) [ Time Frame: Change from baseline CPAP use at six months post Patent Foramen Ovale Closure ]CPAP use = the hours of use per 24 hour period. This is recorded by the CPAP device.
- Cardiovascular events (CV) [ Time Frame: Six months post Patent Foramen Ovale Closure ]Incidence of fatal and non-fatal CV events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02771561
|Contact: Stephanie Clutterbuck, PhDfirstname.lastname@example.org|
|Contact: Victoria Stoneman, PhDemail@example.com|
|Papworth Hospital NHS Foundation Trust||Recruiting|
|Papworth Everard, Cambridgeshire, United Kingdom, CB23 3RE|
|Contact: Stephanie Clutterbuck, PhD 01480364169 firstname.lastname@example.org|
|Contact: Victoria Stoneman, PhD 01480364823 email@example.com|
|Principal Investigator: Stephen Hoole, BM BCh|
|Sub-Investigator: Michael Davies, MB BS|
|Principal Investigator:||Stephen Hoole, BM BCh||Papworth Hospital NHS Foundation Trust|
|Principal Investigator:||Michael Davies, MB BS||Papworth Hospital NHS Foundation Trust|