Observational studySleep & breathing = Schlaf & Atmung2025
Validation of a novel mask-based device for monitoring of comprehensive sleep parameters and sleep disordered breathing.
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 NCT06224972 (Usability and Performance Assessment of DormoTech VLAB), 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.
Usability and Performance Assessment of DormoTech VLAB
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThis study aimed to validate the new DormoTech Vlab device's performance, usability, and validity as a sleep test and physiological data recorder. The novel device has been designed for patient comfort, ease of use, and home-based assessment of sleep disordered breathing and other sleep-related measurements.
methodsForty-seven adults (mean age = 52 years, 42% female, body mass index 29.4 kg/m
resultsThe AHI was 21.7 ± 24.2 events/h (mean ± standard deviation) using the Vlab device versus 21.5 ± 23.9 events/h for gold standard PSG Nox A1 (p = 0.7). When AHI was grouped by severity, inter-test agreement was high (Cohen's kappa = 0.97). Results between the two systems were largely similar in the secondary endpoints, with high correlation between the two systems, and statistically significant (p < 0.05) differences only in REM latency measurements. The Vlab device provides similar sleep study data to conventional gold standard PSG and clinically near-identical test interpretation in almost all cases.
conclusionBased on these results, the Vlab device can be considered substantially equivalent to the reference Nox A1 system in terms of usability, efficacy, and validity. CLINICAL
trial registrationTrial name: Evaluation of the Usability and Performance Assessment of the DormoTech VLAB Device as a Home Sleep Test Identification number: NCT06224972. Date of Registration: 2023-12-06.
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