Sleep Apnea CardioVascular Endpoints study – An investigation of continuous positive airway pressure for the treatment of obstructive sleep apnea to prevent cardiovascular disease.

Phase 3

Completed

• Conditions: Obstructive Sleep Apnea; Cardiovascular Disease; Respiratory - Sleep apnoea; Cardiovascular - Coronary heart disease; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12608000409370
• Lead Sponsor: Respironics Sleep and Respiratory Research Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-08-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

1. Males and females, any race, and aged between 45 and 75 years
2. Evidence of established coronary or cerebrovascular disease as evident by;
(a) Coronary artery disease.
i. Previous MI (greater than or equal to 90 days prior to ApneaLinkTM assessment); or
ii. Stable angina or unstable angina (Clinical event greater than or equal to 30 days and confirmatory test equal to or greater than 7 days prior to ApneaLinkTM assessment) defined as either greater than or equal to 70% diameter stenosis of at least one major epicardial artery segment, or greater than or equal to 50% diameter stenosis of the left main coronary artery, or greater than 50% stenosis in at least two major epicardial arteries, or positive stress test (ST depression greater than or equal to 2 mm or a positive nuclear perfusion scintigram); or
iii. Multi-vessel percutaneous angioplasty (PTCA) and/or stent greater than or equal to 90 days prior to ApneaLinkTM assessment; or
iv. Multi-vessel coronary artery bypass surgery (CABG) greater than 1 year prior to ApneaLinkTM assessment
(b) Cerebrovascular disease
i. Previous stroke (includes definite or presumed cerebral ischaemia/infarction and intracerebral but not subarachnoid haemorrhage) greater than or equal to 90 days prior to ApneaLinkTM assessment; or or minor disabling stroke with minimal residual neurological disability (modified Rankin Score of ‘0 equal to no symptoms’ or ‘1 equal to No significant disability despite symptoms, able to carry out all usual duties and activities’ within 7 days of stroke onset) greater than or equal to 7 days prior to ApneaLinkTM assessment; or
ii. Previous transient ischaemic event (TIA) of the brain or retina (symptoms less than 24 hours) but not of presumed vertebrobasilar system ischemia. The TIA diagnosis must be confirmed by a suitably qualified clinician (greater than or equal to 7 days but less than 1 year prior to ApneaLinkTM assessment)
3. Patients have moderate-severe OSA (equivalent to apnea plus hypopneas index [AHI] greater than 30 per hour of sleep) as determined by a greater than 4% oxygen dip rate greater than 12/ h on overnight testing using the ApneaLinkTM device and confirmed by the SAVE corelab in Adelaide upon receipt of the ApneaLink data; and
4. Patients are able and willing to give appropriate informed consent

Exclusion Criteria

Patients will be excluded from entry if ANY of the criteria listed below are met:
1. Any condition that in the opinion of the responsible physician or investigator makes the potential participant unsuitable for the study. For example,
i. co-morbid disease with severe disability or likelihood of death
ii. significant memory, perceptual, or behavioural disorder
iii. neurological deficit (eg. limb paresis) preventing self administration of the CPAP mask
iv. contraindication to CPAP use e.g. pneumothoraxv residence sufficiently remote from the clinic to preclude follow-up clinic visits
2. Any planned coronary or carotid revascularisation procedure in the next 6 months
3. Severe respiratory disease defined as
i. severe chronic obstructive pulmonary disease (FEV1/FVC greater than 70% and FEV1 less than 50% predicted), or
ii. resting, awake SaO2 less than 90% by ApneaLinkTM device
4. New York Heart Association (NYHA) categories III-IV of heart failure
5. Other household member enrolled in SAVE trial or using CPAP
6. Prior use of CPAP treatment for OSA
7. Increased risk of a sleep-related accident and/or excessive daytime sleepiness, defined by any one of the following:
i. driver occupation (eg truck, taxi)
ii. ‘fall-asleep’ accident or ‘near miss’ accident in previous 12 months
iii. high (greater than 15) score on the Epworth Sleepiness Scale
8. Severe nocturnal desaturation documented on the ApneaLinkTM device as i. greater than 10% overnight recording time with arterial oxygen saturation of less than 80%
9. Cheyne-Stokes Respiration (CSResp)
i. CSResp identified on ApneaLinkTM nasal pressure recording by typical crescendo-decrescendo pattern of respiration with associated apneas and/or hypopneas in the absence of inspiratory flow limitation.
ii. patients excluded if greater than 50% of nasal pressure – defined apneas and hypopneas judged to be due to CSResp.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be a composite of the CV endpoints of CV death, non-fatal acute myocardial infarction, non-fatal stroke, hospital admission for heart failure, and new hospitalisation for unstable angina or transient ischaemic attack. These reported events will be verified from investigator reports, hospital records (including where applicable results of serial ECGs and cardiac enzymes, CT brain scans, chest radiographs and other investigations) and post-mortem or death certificates.[Reviewed 6-monthly; average patient follow up, 4.5 years]