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#Apnealink driver trial

Important Note about Optional Tape: The ResMed ApneaLink Air video shows usage of hospital tape with your home sleep test. Your device has been thoroughly cleaned for your usage. A white film may be visible on the hinge elbow which is due to the natural mineral film deposit left by tap water following the washing of the equipment. Some orange discoloration may occur due to the germicidal disinfectant. Important Note about Device: The ResMed ApneaLink Air is individually cleaned prior to usage. *** READ this IMPORTANT INFORMATION FIRST *** If you experience an emergency during your home sleep test, do not call or return to SleepSomatics. Please immediately call 911. This is a self-administered test. Please watch the ApneaLink Air user video and read all directions before beginning your test. Provided below are the SleepSomatics patient directions for the ResMed ApneaLink Air Take-Home Sleep Apnea Test.

Contraindication to CPAP use e.g.This page is for the ApneaLink Air home study device.

limb paresis) preventing self administration of the CPAP mask

Significant memory, perceptual, or behavioural disorder.

Co-morbid disease with severe disability or likelihood of death.

Any condition that in the opinion of the responsible physician or investigator makes the potential participant unsuitable for the study.

Able and willing to give appropriate informed consent.

Previous transient ischaemic event (TIA) of the brain or retina (symptoms 30 per hour of sleep as determined by a ≥ 4% oxygen dip rate > 12/ h on overnight testing using the ApneaLink™ device, and confirmed by the SAVE core lab in Adelaide upon receipt of the ApneaLink™ data.

Minor disabling stroke with minimal residual neurological disability and modified Rankin Score of '0 = no symptoms' or '1 = No significant disability despite symptoms, able to carry out all usual duties and activities' within 7 days of stroke onset at ≥7 days prior to ApneaLink™ assessment.

Previous stroke includes definite or presumed cerebral ischaemia/infarction and intracerebral but not subarachnoid haemorrhage equal to or greater than 90 days prior to ApneaLink™ assessment.

Previous MI equal to or greater than 90 days prior to ApneaLink™ assessment.

Positive stress test with ST depression equal to or greater than 2 mm or a positive nuclear perfusion scintigram.

>50% stenosis in at least two major epicardial arteries.

≥50% diameter stenosis of the left main coronary artery.

≥70% diameter stenosis of at least one major epicardial artery segment.

Stable angina or unstable angina clinical event equal to or greater than 30 days and confirmatory test equal to or greater than 7 days prior to ApneaLink™ assessment.Multi-vessel percutaneous angioplasty (PTCA) and/or stent equal to or greater than 90 days prior to ApneaLink™ assessment.Multi-vessel coronary artery bypass surgery (CABG) >1 year prior to ApneaLink™ assessment.Evidence of established coronary artery disease.Contact the study team to discuss study eligibility and potential participation.

#Apnealink driver trial

There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Guidelines differ from study to study, and identify who can or cannot participate. Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. The overall aim of SAVE is to determine if CPAP can reduce the risk of heart attack, stroke or heart failure for people with OSA. CPAP has been shown to effectively reduce snoring, obstructive episodes and daytime sleepiness and to modestly reduce blood pressure and other risk factors for cardiovascular disease. The standard therapy for symptomatic OSA is continuous positive airway pressure (CPAP). Research indicates that OSA may be a modifiable risk factor for cardiovascular disease due to its association with hypertension, stroke, heart attack and sudden death. This can occur many times during sleep and is known to cause sleepiness and poor concentration during the day.

Obstructive Sleep Apnea (OSA) is a condition in which a person stops breathing for several seconds at a time due to relaxation of the throat muscles. Sponsor Protocol Number: SAVE About this study