Pregnancy outcomes in infertility patients diagnosed with sleep disordered breathing with wireless wearable sensors

Objective: To study the feasibility of home-based assessment of sleep disordered breathing (SDB) on early pregnancy success after in vitro fertilization with novel wearable sensors. Design: Prospective observational study. Setting: Patients 18 to 45 years old undergoing autologous IVF at an academic infertility center. Patients: 30 women (24–44 years old) Intervention: Participants provided medical history, completed sleep surveys, and a single night of home sleep monitoring prior to IVF with a novel, FDA-cleared wireless sensor system (ANNE® Sleep, Sibel Health), to collect continuous measurements of heart rate, respiratory rate, pulse oxygenation, respiratory effort/snoring, peripheral arterial tonometry, pulse arrival time, and pulse transit time, an accepted surrogate of continuous blood pressure generated by pulse arrival time and pulse transit time. Sleep nights were reviewed to derive the apnea hypopnea index (AHI), defined as the average number of apnea or hypopnea events per hour. An AHI of greater than or equal to 5 events/hour was considered abnormal. Main outcome measure: Rate of clinical pregnancy (defined as intrauterine gestational sac with a yolk sac) after IVF. Logistic regression models were used to estimate the unadjusted and adjusted odds ratio. Results: The overall rate of sleep disordered breathing of any severity was 57%. Participants with SDB had a mean AHI of 13.4 compared to 2.7 events/hr (p<0.01), were younger, and more likely to have polycystic ovary syndrome. Of the 29 patients undergoing an embryo transfer, clinical pregnancy and livebirth occurred in 35% of women with SDB compared to 58% without SDB (p = 0.22). After adjusting for age, SDB reduced pregnancy rates but was not statistically significant (aOR 0.23, 95% CI: 0.04–1.5, p = 0.12). Though polycystic ovary syndrome was associated with higher rates of SDB it was not independently associated with lower pregnancy rates. Conclusion: Screening for sleep disordered breathing using home-based wireless, wearable sensors was well accepted and easily performed by infertile patients in this cohort. Sleep disordered breathing of any severity was associated with an 77% (95% CI: 0.08–1.8) lower likelihood of clinical pregnancy and live birth independent of underlying diagnosis. Future larger studies will be needed to understand the role of sleep disordered breathing and IVF outcomes.