PFO Closure for Obstructive Sleep Apnoea

NCT02771561 | Unknown DMC

• 1 other identifier: P01725
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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; Gore™ septal occluder device

Outcome Measures

Primary Outcomes (7)

• Change in Epworth Sleepiness Scale

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

• Change in Apnoea-Hypopnoea Index

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

• Change in Oxygen Desaturation Index

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

• Change in Six Minute Walk Test

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

• Change in Sleep Apnea Quality of Life Index (SAQLI)

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

• Change in Functional Outcomes of Sleep Questionnaire (FOSQ)

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

• Change in Short Form (36) Health Survey (SF36)

  Change from baseline SF36 at six months post Patent Foramen Ovale Closure

Secondary Outcomes (2)

• Change in Continuous Positive Airway Pressure (CPAP)

  Change from baseline CPAP use at six months post Patent Foramen Ovale Closure

• Cardiovascular events (CV)

  Six months post Patent Foramen Ovale Closure

Study Arms (1)

Patent Foramen Ovale Closure

OTHER

All eligible participants undergo a patent foramen ovale closure procedure

Procedure: Patent Foramen Ovale Closure

Interventions

Patent Foramen Ovale Closure PROCEDURE

Transoesophageal guided percutaneous patent foramen ovale closure using Gore™ septal occluder device

Patent Foramen Ovale Closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead

Study Sites (1)

Papworth Hospital NHS Foundation Trust

Papworth Everard, Cambridgeshire, CB23 3RE, United Kingdom

RECRUITING

Related Publications (14)

• 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.

  PMID: 16202118 BACKGROUND

• Beelke 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.

  PMID: 12489891 BACKGROUND

• Bradley 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.

  PMID: 4066566 BACKGROUND

• Engleman 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.

  PMID: 9708223 BACKGROUND

• Johansson 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.

  PMID: 17005584 BACKGROUND

• La 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.

  PMID: 11319197 BACKGROUND

• Marin 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.

  PMID: 15781100 BACKGROUND

• Shanoudy 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.

  PMID: 9440574 BACKGROUND

• Silver 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.

  PMID: 17561600 BACKGROUND

• Smith 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.

  PMID: 8847442 BACKGROUND

• van 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.

  PMID: 1568978 BACKGROUND

• Young 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.

  PMID: 19743755 BACKGROUND

• Young 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.

  PMID: 8464434 BACKGROUND

• Zoccali 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.

  PMID: 11856778 BACKGROUND

MeSH Terms

Conditions

Foramen Ovale, Patent; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Stephen Hoole, BM BCh

  Papworth Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Michael Davies, MB BS

  Papworth Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Clutterbuck, PhD

CONTACT

01480364169; stephanie.clutterbuck@nhs.net

Victoria Stoneman, PhD

CONTACT

01480364823; victoria.stoneman@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: May 13, 2016
• Study Start: April 1, 2013
• Primary Completion: April 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 13, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)