The validity and reliability of a portable device for the diagnosis of Obstructive Sleep Apnoea in patients with Atrial Fibrillation: SAFARI

Not Applicable

Recruiting

• Conditions: Obstructive Sleep Apnoea; Respiratory - Sleep apnoea; Atrial Fibrillation; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12616001016426
• Lead Sponsor: Department of Respiratory and Sleep Medicine, Royal North Shore Hospital, NSLHD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 99

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the validityof a portable device as a screening tool for OSA in AF patients. This includes sensitivity, specificity, receiver operating characteristic (ROC), positive and negative predictive values, as compared with the gold standard of PSG.[Following both ApneaLink and PSG assessments]

Secondary Outcome Measures

Name	Time	Method
tility of phenotypic characteristics for the prediction of OSA in an AF cohort. These include: body mass index (BMI), neck circumference, craniofacial photogrammetry, co-morbidities including hypertension and diabetes, respiratory illness, sleep questionnaires (viz. Epworth Sleepiness Score, Berlin Questionnaire), AF characteristics (ie. paroxysmal vs chronic, and treatments received), echocardiographic parameters, plasma biomarkers (CRP, BNP, others), This outcome will be assessed by correlation of these characteristics obtained by patient interview, clinical assessment, photography, blood tests and medical records with PSG findings.[Following both ApneaLink and PSG assessments.];Prevalence of OSA in an AF cohort as per PSG findings[Following PSG assessment.]