The Impact of Early Diagnosis and Treatment of Obstructive Sleep Apnea on Hospital Readmission in Hospitalized Cardiac Patients: the CV Readmit Clinical Trial

Study investigators have designed a single-center, randomized control trial to evaluate the impact of early diagnosis and treatment of obstructive sleep apnea (OSA) in hospitalized cardiac patients on hospital readmission, symptoms, and healthcare utilization. This study targets a high risk population (hospitalized cardiac patients) and targets early initiation of continuous positive airway pressure (CPAP) therapy in patients diagnosed with OSA. Investigators intend to enroll all consenting participants hospitalized with a primary cardiac diagnosis, which include congestive heart failure, arrhythmia's, and acute coronary syndromes. The study is unique and the answer to its question - whether early diagnosis of OSA and initiation of and adherence to CPAP therapy in hospitalized cardiac patients will reduce 30-day readmission rates - is unknown. The objective is twofold: to improve quality of care and decrease preventable hospitalizations through early diagnosis and implementation of this early diagnosis and intervention model for this subset of patients may slow progression of cardiac disease, offset a large public health and financial burden, and improve overall outcomes.

Study investigators believe that the study, which involves human subjects, is in accordance with general ethical principles. It should be noted that diagnosis and subsequent treatment of OSA during hospitalization is not part of routine practice, and that the control group truly would follow "usual care". Moreover, patients who are deemed very sick (as outlined in the exclusion criteria) will be excluded from the study. Finally, half of enrolled participants will receive early CPAP therapy which may potentially benefit those patients beyond what is currently "usual care".

Study Design

The study is a single-center, randomized control trial designed to evaluate the impact of early diagnosis and treatment of obstructive sleep apnea (OSA) in hospitalized cardiac patients on hospital readmission, symptoms, and healthcare utilization. Consecutive patients who meet inclusion criteria hospitalized with a primary diagnosis of heart failure, arrhythmia, or acute coronary syndrome will be asked to participate in the study. Patients who agree and sign consent will undergo a portable sleep study to diagnose OSA-predominant sleep disordered breathing. Patients will also complete a questionnaire packet consisting of the following standardized questionnaires: sleep history questionnaire, Epworth Sleepiness Scale (ESS), EQ5D-5L, and PROMIS questionnaire. Each patient who meets inclusion criteria and consents to the study will undergo an inpatient portable sleep study (ApneaLink, Resmed Corp). This is a Type III study which is an unattended study that measures nasal pressure, respiratory effort, oxygen saturation, and body position. A study investigator will apply the portable device, and a board-certified sleep medicine physician (co-investigators) will interpret these studies. The study will be performed while the patient is on room air (not on oxygen), thus the study may not be applied on the first hospitalized night (if oxygen therapy is required), but delayed until the patient is appropriate to be off oxygen.

A diagnosis of OSA will be made if the apnea-hypopnea index with 4% oxygen desaturation is greater than 5 (AHI4%≥5) with at least 50% of events consistent with obstructive rather than central physiology. Study participants with OSA will then be randomized into one of two pathways: Intervention Pathway and Usual Care Pathway.