Sleep Disorders

Post-Discharge Telemedicine Motivational Enhancement in Heart Failure and Obstructive Sleep Apnea Randomized Clinical Trial: Design and Description of Baseline Characteristics

Despite evidence suggesting that Positive Airway Pressure (PAP) in patients with Acute Decompensated Heart Failure(ADHF) with Obstructive Sleep Apnea (OSA) confers improvement of cardiovascular outcomes, PAP adherence remains exceedingly low. It was hypothesized that motivational enhancement (ME) via a telemedicine intensive approach improves PAP adherence post-discharge in hospitalized patients with ADHF and OSA. Telemedicine Intensive Motivational Enhancement (TIME) (NCT04752462) is an ongoing randomized clinical trial designed to investigate telemedicine ME effect on post0discharge PAP adherence, rehospitalizations, and patient-reported outcomes compared to standard of care at 6 and 6 months in patients admitted with ADHF and in-hospital diagnosis (respiratory event index, REI>5).

Overall Kansas Cardiomyopathy Score - Respiratory Event Index

2023

Overall Kansas Cardiomyopathy Score - Percent Sleep Time Oxygenation <90%

2023

The center described baseline characteristics of N=72 patients currently enrolled. Unadjusted and adjusted linear models were used to describe associations of OSA measures (Respiratory Event Index, REI, and percentage of recording time <90% SaO₂, T90) with Kansas City Cardiomyopathy Score (KCCQ) which measures symptoms, physical and social limitations, and quality of life in patients with heart failure. Adjusted models included age, sex, race, and body mass index (BMI). Characteristics of the 72 patients currently enrolled are: age: 60±13 years, 40% women, 40% black race, BMI of 35±7 kg/m², left ventricular ejection fraction: 39±17%, REI: 25±14, T90: 19±17%, and Epworth Sleepiness Scale: 8 [IQR, 3-10]. The most common comorbidities were hypertension 53%, atrial fibrillation 23%, valvular disease 12%, myocardial infarction 12%, and diabetes 32%. Self-reported health status at baseline was poor with a KCCQ score of 31±21. In adjusted analyses, for each unit increase of REI and T90, there was not a significant association with overall KCCQ (-0.04, 95% CI: -0.47-0.4, p=0.87; 0.06, 95% CI: -0.31-0.44, p=0.74). The TIME trial is designed to elucidate the effect of ME through telemedicine on PAP adherence and patient outcomes post-discharge in patients with ADHF and OSA. In these cross-sectional preliminary results, OSA severity was not associated with lower KCCQ scores.