Observational studySleep & breathing = Schlaf & Atmung2025
Feasibility and acceptance of self-applied home type-II PSG studies with a patch-based device.
Observational study in Sleep & breathing = Schlaf & Atmung, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06881667 (US Development and Evaluation Study of a Patch-Based PSG System), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
US Development and Evaluation Study of a Patch-Based PSG System
Who cites it
0 citing papers in PubMed.
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Authors and funding
6 authors.
Funding
Abstract
purposeOnera 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.
methods41 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.
resultsOf 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.
conclusionsThe 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).
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