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PFO Closure for Obstructive Sleep Apnoea (PCOSA-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Papworth Hospital NHS Foundation Trust

Brief 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.


Condition or disease Intervention/treatment Phase
Patent Foramen Ovale Obstructive Sleep Apnea Procedure: Patent Foramen Ovale Closure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change in Epworth Sleepiness Scale [ Time Frame: Change from baseline Epworth Sleepiness Scale score at six months post Patent Foramen Ovale Closure ]
  2. Change in Apnoea-Hypopnoea Index [ Time Frame: Change from baseline Apnoea-Hypopnoea Index at six months post Patent Foramen Ovale Closure ]
  3. Change in Oxygen Desaturation Index [ Time Frame: Change from baseline Oxygen Desaturation Index at six months post Patent Foramen Ovale Closure ]
  4. Change in Six Minute Walk Test [ Time Frame: Change from baseline six minute walk test at six months post Patent Foramen Ovale Closure ]
  5. Change in Sleep Apnea Quality of Life Index (SAQLI) [ Time Frame: Change from baseline SAQLI at six months post Patent Foramen Ovale Closure ]
  6. Change in Functional Outcomes of Sleep Questionnaire (FOSQ) [ Time Frame: Change from baseline FOSQ at six months post Patent Foramen Ovale Closure ]
  7. Change in Short Form (36) Health Survey (SF36) [ Time Frame: Change from baseline SF36 at six months post Patent Foramen Ovale Closure ]

Secondary Outcome Measures :
  1. 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.

  2. Cardiovascular events (CV) [ Time Frame: Six months post Patent Foramen Ovale Closure ]
    Incidence of fatal and non-fatal CV events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 informed consent or comply with the protocol
  • Anatomically unsuitable for percutaneous PFO closure with Gore™ septal occluder device.

Information from the National Library of Medicine

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


Contacts
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Contact: Stephanie Clutterbuck, PhD 01480364169 stephanie.clutterbuck@nhs.net
Contact: Victoria Stoneman, PhD 01480364823 victoria.stoneman@nhs.net

Locations
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United Kingdom
Papworth Hospital NHS Foundation Trust Recruiting
Papworth Everard, Cambridgeshire, United Kingdom, CB23 3RE
Contact: Stephanie Clutterbuck, PhD    01480364169    stephanie.clutterbuck@nhs.net   
Contact: Victoria Stoneman, PhD    01480364823    victoria.stoneman@nhs.net   
Principal Investigator: Stephen Hoole, BM BCh         
Sub-Investigator: Michael Davies, MB BS         
Sponsors and Collaborators
Papworth Hospital NHS Foundation Trust
Investigators
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Principal Investigator: Stephen Hoole, BM BCh Papworth Hospital NHS Foundation Trust
Principal Investigator: Michael Davies, MB BS Papworth Hospital NHS Foundation Trust
Publications:

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Responsible Party: Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02771561    
Other Study ID Numbers: P01725
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to make individual participant data available.
Keywords provided by Papworth Hospital NHS Foundation Trust:
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
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Foramen Ovale, Patent
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities