Optimizing Obstructive Sleep Apnea Therapy in Patients with Acute Coronary Syndrome: A Pilot Randomised Control Trial

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease; Obstructive Sleep Apnea; Cardiovascular - Coronary heart disease; Respiratory - Sleep apnoea

• Registration Number: ACTRN12620000050954
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-22
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients with a recent (within 12 months of diagnosis) presentation of acute coronary syndrome (unstable angina, ST elevated myocardial infarction (EMI), non-STEMI).
2. Patients diagnosed with moderate to severe obstructive sleep apnoea with significant hypoxia defined as an Oxygen Saturation Index 3% (ODI 3%) > 10 events/hour on polysomnogram.
3. Clinically suitable for PAP and/or OAT treatment.
4. Willingness to undergo either PAP, OAT or usual care for 6 months.

Exclusion Criteria

1. Previous treatment for obstructive sleep apnea.
2. Contraindications to CPAP (severe nasal obstruction) or oral appliance therapy (insufficient teeth or dental health issues).
3. Women who are lactating or pregnant
4. Driving risk, report an accident (or near miss accident) because of sleepiness in the last 6 months
5. Need for immediate therapy as assessed by treating sleep physician.
6. Patients with a history of psychological illness or conditions such as to interfere with the patients ability to understand the requirements of the study
7. Coexisting sleep disorder, shift work, regular use of sedatives or narcotics, pre-existing lung disease (moderate to severe chronic obstructive pulmonary disease) or psychiatric disease; chronic kidney disease (eGFR<60).
8. Central sleep apnea (defined as >20% of respiratory events being central events, rather than obstructive events)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Daily usage data (mean hours used per day) of OSA therapy will be collected from a cloud based patient management system and patient diary.[ At 6 months after commencement of intervention period.]