Feasibility and acceptance of self-applied home type-II PSG studies with a patch-based device.

PURPOSE: Onera Health has developed the first wireless, patch-based type-II polysomnography (PSG) system, the Onera Sleep Test System (STS) 1 for self-applied, home sleep studies. This multicenter observational study aimed to assess the success rate of the device in a home setting and gather participant feedback. METHODS: 41 patients (age: 48.7 ± 16.9, 58.7% male) with a suspected sleep disorder referred for a PSG were included in the study. Participants received minimal instruction at the clinic and were mailed the Onera STS 1 with instructions to complete a home sleep study. After completion, they returned the device by mail. At the fulfilment center data were uploaded to a secure portal and double-scored independently per AASM criteria. RESULTS: Of the 41 home sleep studies, 83% were of sufficient quality for diagnosis by an expert assessment, and 87.8% met rule-based success criteria. Signal quality was high, with ~80% of each signal providing over 5 hours of scorable data. Interscorer agreement was excellent for all sleep parameters, with the highest agreement in AI (0.98), AHI (0.97), REM (0.95) and OAI (0.95). Participant usability and satisfaction was high, 87.8% experienced no problems with device application, 98.1% found the self-application time acceptable, and 90.7% indicated they would recommend the device. CONCLUSIONS: The patch-based home PSG device demonstrated high success rates with excellent signal quality, high interscorer agreement, and overall high participant satisfaction. The device appears to be a viable alternative to in-lab PSG, offering a user-friendly solution for comprehensive sleep assessment in a home setting. REGISTRATION: The observational study described in this manuscript was retrospectively registered with an internationally recognized trial registry (ClinicalTrials.gov, URL: https://clinicaltrials.gov/study/NCT06881667 , Name: " US Development and Evaluation Study of a Patch-Based PSG system", ID: NCT06881667, Date: February 26th, 2025).