Validation of self-applied unattended polysomnography using Somte V2 PSG (Somte) for diagnosis of obstructive sleep apnoea (OSA) in pregnant women in early to mid-gestation

Polysomnography (PSG) may be completed in the home environment (unattended), and when self-applied, allow the collection of data with minimal healthcare worker intervention. Self-applied, unattended PSG in the home environment using Somte PSG V2 (Somte) has not been validated in pregnant women in early to mid-gestation. We undertook a study to evaluate the accuracy of Somte compared to attended PSG. The agreement between apnoea hypopnea index (AHI) and respiratory disturbance index (RDI) scores in Somte and PSG in early to mid-gestation were assessed. Pregnant women (≤ 24 weeks gestation) were scheduled for PSG and Somte within a 7-day window, in any order. Somte were self-applied and completed in the home. Somte were scored blinded to PSG result. AHI was the primary outcome of interest, though an AHI ≥ 5 or RDI ≥ 5 on PSG was considered diagnostic of Obstructive Sleep Apnoea (OSA). AHI, RDI, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) was calculated and receiver operating characteristic (ROC) curves were produced. Bland–Altman plots were used to determine agreement. Technical issues occurring during tests were explored. Twenty-four participants successfully completed both tests between March 2021 and January 2023. PSG were completed at around 14.1 weeks’ gestation (IQR 13.4, 15.7). The time interval between Somte and PSG was a median of 4 days (IQR 2, 7 (range 1–12)). Five (20.8