Feasibility and impact of personalized therapy for obstructive sleep apnea in patients with acute coronary syndrome: a pilot randomized controlled trial

BACKGROUND: Recent neutral randomized controlled trials have created clinical equipoise around the treatment of obstructive sleep apnea (OSA) for the secondary prevention of cardiovascular disease. These findings are in part limited by poor compliance, lack of treatment optimization and personalization strategies with OSA therapy. This pilot study aims to assess the feasibility and impact of a personalized OSA treatment program on therapy compliance and cardiovascular health in patients with acute coronary syndrome (ACS) diagnosed with OSA. METHODS: Patients with ACS and OSA (oxygen desaturation index 3% > 10 events/hour) will be recruited and randomized to receive either personalized OSA therapy (PT) or usual care (UC) with six-month follow-up. The PT group will receive standard medical care for ACS plus the choice of continuous positive airway pressure and/or mandibular advancement device therapy for OSA. Treatment optimization strategies including treatment acclimatization, augmented support and patient engagement tools will be implemented. The UC group will receive standard medical care for ACS but no treatment for OSA. The primary outcome is the feasibility of personalized treatment for OSA assessed by study and treatment acceptance, and treatment compliance. Secondary outcomes include treatment effectiveness, cardiovascular health markers and patient reported outcomes across the six-months intervention. DISCUSSION: This study will provide novel findings on the impact of personalized and optimized OSA therapy on patient compliance, preliminary treatment effectiveness and health outcomes in patients with established cardiovascular disease. Such novel data will inform the design and delivery of future large scale randomized clinical trials to assess cardiovascular disease benefit in patients with OSA. TRIAL REGISTRATION: ACTRN 12620000050954. Registered 22 January 2020, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378536&isReview=true.