None listed
Conditions
Brief summary
Mounting evidence highlights the importance of screening for obstructive sleep apnoea in patients with atrial fibrillation. Treating obstructive sleep apnoea in these patients may improve outcomes, such as improving the risk of recurrence of atrial fibrillation after Pulmonary Vein Isolation procedures. We will examine the validity of a portable sleep study device (ApneaLink) for the diagnosis of Obstructive Sleep Apnoea in patients with Atrial Fibrillation.
Interventions
This will be a prospective observational diagnostic accuracy study to compare the test characteristics of the index test (ApneaLink) to the gold standard polysomnography (PSG) for the diagnosis of OSA in patients with AF. Additionally, the epidemiology of OSA in this patient group will be examined.
ApneaLink, is a portable, limited channel sleep study device, which will be worn at home by the patient for one night. This device includes overnight oximetry (worn on the finger), nasal airflow si
This will be a prospective observational diagnostic accuracy study to compare the test characteristics of the index test (ApneaLink) to the gold standard polysomnography (PSG) for the diagnosis of OSA in patients with AF. Additionally, the epidemiology of OSA in this patient group will be examined. ApneaLink, is a portable, limited channel sleep study device, which will be worn at home by the patient for one night. This device includes overnight oximetry (worn on the finger), nasal airflow signal detected via a nasal cannula as well as respiratory effort signal detected via a band worn around the chest. It generates an Apnoea Hypopnoea index (AHI) using total recording time as the denominator. ApneaLink and in-laboratory sleep study (PSG) will be performed within one week of one another. All patients will undergo both of these diagnostic tests, though the order will be randomised. Interpreting physicians of each study will be blinded to the results of the other. The Index test (ApneaLink) will be compared to in-laboratory sleep study as the gold standard, and the validity examined. The epidemiology of OSA in the AF population examined as per the secondary aims.
Sponsors
Department of Respiratory and Sleep Medicine, Royal North Shore Hospital, NSLHD
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sequential subjects with paroxysmal or persistent AF referred for Pulmonary Vein Isolation (PVI) at a tertiary referral institution OR Sequential subjects presenting with AF at a tertiary referral institution emergency department. * Willingness and capacity to give written informed consent and willingness to comply with the study.
Exclusion criteria
* Age < 18. * Pregnant women. * People highly dependent on medical care (eg intubated, intensive care patients, GCS < 15). * Life expectancy < 12 months. * Patients with a history of psychological illness such as to interfere with the patient’s ability to understand the requirements of the study. * Those otherwise unable to give their own written informed consent. * Previous formal PSG diagnosis of OSA.
Outcome results
None listed