ArticleSleep2025
The evaluation of a novel single-lead biopotential device for home sleep testing.
Article in Sleep, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05035992 ([Trial of device that is not approved or cleared by the U.S. FDA]), which is not on this map. Cited by 3 papers.
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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.
[Trial of device that is not approved or cleared by the U.S. FDA]
Who cites it
3 citing papers in PubMed.
- Smart Wearable EEG Devices: A Review of Lightweight, Multi-Sensor Systems for Sleep and Everyday Neurophysiology.Biosensors · 2026Review
- Evaluating the performance of wearable EEG sleep monitoring devices: a meta-analysis approach.npj biomedical innovations · 2025Article
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Authors and funding
4 authors.
Funding
Abstract
STUDY
objectivesThis paper reports on the clinical evaluation of the sleep staging performance of a novel single-lead biopotential device.
methodsOne hundred and thirty-three patients suspected of obstructive sleep apnea were included in a multi-site cohort. All patients underwent polysomnography and received the study device, a single-lead biopotential measurement device attached to the forehead. Clinical endpoint parameters were selected to evaluate the device's ability to determine sleep stages. Finally, the device's performance was compared to the clinical study results of comparable devices.
resultsConcurrent PSG and study device data were successfully acquired for 106 of the 133 included patients. The results of this study demonstrated significant similarity in overall sleep staging performance (five-stage Cohen's Kappa of 0.70) to the best-performing reduced-lead biopotential device to which it was compared (five-stage Cohen's Kappa of 0.73). Contrary to the comparator devices, the study device reported a higher Cohen's Kappa for rapid eye movement (REM) (0.78) compared to N3 (0.61), which can be explained by its particular measuring electrode placement (diagonally across the lateral cross-section of the eye). This placement was optimized to ensure the polarity of rapid eye movements could be adequately captured, enhancing the capacity to discriminate between N3 and REM sleep when using only a single-lead setup.
conclusionsThe results of this study demonstrate the feasibility of incorporating a single-lead biopotential extension in a reduced-channel home sleep apnea testing setup. Such incorporation could narrow the gap in the functionality of reduced-channel home sleep testing and in-lab polysomnography without compromising the patient's ease of use and comfort. CLINICAL TRIALS: NCT05035992, A Validation Study of the NightOwl Head Sensor https://clinicaltrials.gov/ct2/show/NCT05035992.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.