{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T11:39:10Z","timestamp":1782819550053,"version":"3.54.5"},"reference-count":20,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2025,1,20]],"date-time":"2025-01-20T00:00:00Z","timestamp":1737331200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,1,20]],"date-time":"2025-01-20T00:00:00Z","timestamp":1737331200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100005005","name":"Ben-Gurion University","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100005005","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Sleep Breath"],"published-print":{"date-parts":[[2025,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:sec>\n            <jats:title>Purpose<\/jats:title>\n            <jats:p>This study aimed to validate the new DormoTech Vlab device\u2019s 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.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>Forty-seven adults (mean age\u2009=\u200952 years, 42% female, body mass index 29.4\u00a0kg\/m<jats:sup>2<\/jats:sup>) underwent simultaneous testing with the DormoTech Vlab device and routine full polysomnography (PSG) using the Nox A1 system (K192469, Nox Medical). The sleep studies were manually and independently scored according to recommended guidelines. The primary outcome measure was the apnea-hypopnea index (AHI) and its corresponding conventional severity level (i.e., normal, mild, moderate, severe). Secondary endpoints included other standard PSG parameters.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>The AHI was 21.7\u2009\u00b1\u200924.2 events\/h (mean\u2009\u00b1\u2009standard deviation) using the Vlab device versus 21.5\u2009\u00b1\u200923.9 events\/h for gold standard PSG Nox A1 (<jats:italic>p<\/jats:italic>\u2009=\u20090.7). When AHI was grouped by severity, inter-test agreement was high (Cohen\u2019s kappa\u2009=\u20090.97). Results between the two systems were largely similar in the secondary endpoints, with high correlation between the two systems, and statistically significant (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.05) 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.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusion<\/jats:title>\n            <jats:p>Based on these results, the Vlab device can be considered substantially equivalent to the reference Nox A1 system in terms of usability, efficacy, and validity.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Clinical Trial Registration<\/jats:title>\n            <jats:p>Trial 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.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1007\/s11325-025-03250-1","type":"journal-article","created":{"date-parts":[[2025,1,20]],"date-time":"2025-01-20T16:34:13Z","timestamp":1737390853000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Validation of a novel mask-based device for monitoring of comprehensive sleep parameters and sleep disordered breathing"],"prefix":"10.1007","volume":"29","author":[{"given":"Benjamin D.","family":"Fox","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Murad","family":"Shihab","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abed","family":"Nassir","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dahlia","family":"Kushinsky","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ofer","family":"Barnea","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Asher","family":"Tal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,1,20]]},"reference":[{"issue":"10","key":"3250_CR1","doi-asserted-by":"publisher","first-page":"zsaa072","DOI":"10.1093\/sleep\/zsaa072","volume":"43","author":"N McArdle","year":"2020","unstructured":"McArdle N, Ward SV, Bucks RS et al (2020) The prevalence of common sleep disorders in young adults: a descriptive population-based study. 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Approval was granted by the IEC committee on ethics of Shamir Medical Center on April 24, 2023, study number 0067-23-ASF.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Informed consent was obtained from all participants included in the study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Financial support for this study was provided by DormoTech Medical. All Vlab devices used in the study were supplied by DormoTech Medical under a collaborative research agreement. Benjamin D. Fox, Murad Shihab, and Asher Tal received support in the form of Vlab devices to perform this study, provided by DormoTech Medical. Asher Tal reports a relationship with DormoTech Medical that includes: board membership. Ofer Barnea reports a relationship with DormoTech Medical that includes: equity or stocks. Abed Nassir reports a relationship with DormoTech that includes: employment and equity or stocks. Abed Nassir, Ofer Barnea has patent #EP3457938B1. Dahlia Kushinsky reports a relationship with DormoTech Medical that includes: employment.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interest"}}],"article-number":"83"}}