{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T18:08:08Z","timestamp":1793383688686,"version":"4.5.0"},"reference-count":31,"publisher":"BMJ","issue":"12","license":[{"start":{"date-parts":[[2021,12,21]],"date-time":"2021-12-21T00:00:00Z","timestamp":1640044800000},"content-version":"unspecified","delay-in-days":20,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Acurable Limited","award":["This research received no specific funding in the"],"award-info":[{"award-number":["This research received no specific funding in the"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,11,15]]},"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>Obstructive sleep apnoea (OSA) is a heavily underdiagnosed condition, which can lead to significant multimorbidity. Underdiagnosis is often secondary to limitations in existing diagnostic methods. We conducted a diagnostic accuracy and usability study, to evaluate the efficacy of a novel, low-cost, small, wearable medical device, AcuPebble_SA100, for automated diagnosis of OSA in the home environment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Settings<\/jats:title>\n                    <jats:p>Patients were recruited to a standard OSA diagnostic pathway in an UK hospital. They were trained on the use of type-III-cardiorespiratory polygraphy, which they took to use at home. They were also given AcuPebble_SA100; but they were not trained on how to use it.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>182 consecutive patients had been referred for OSA diagnosis in which 150 successfully completed the study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Primary outcome measures<\/jats:title>\n                    <jats:p>Efficacy of AcuPebble_SA100 for automated diagnosis of moderate\u2013severe-OSA against cardiorespiratory polygraphy (sensitivity\/specificity\/likelihood ratios\/predictive values) and validation of usability by patients themselves in their home environment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>After returning the systems, two expert clinicians, blinded to AcuPebble_SA100\u2019s output, manually scored the cardiorespiratory polygraphy signals to reach a diagnosis. AcuPebble_SA100 generated automated diagnosis corresponding to four, typically followed, diagnostic criteria: Apnoea Hypopnoea Index (AHI) using 3% as criteria for oxygen desaturation; Oxygen Desaturation Index (ODI) for 3% and 4% desaturation criteria and AHI using 4% as desaturation criteria. In all cases, AcuPebble_SA100 matched the experts\u2019 diagnosis with positive and negative likelihood ratios over 10 and below 0.1, respectively. Comparing against the current American Academy of Sleep Medicine\u2019s AHI-based criteria demonstrated 95.33% accuracy (95% CI (90\u00b762% to 98\u00b710%)), 96.84% specificity (95% CI (91\u00b705% to 99\u00b734%)), 92.73% sensitivity (95% CI (82\u00b741% to 97\u00b798%)), 94.4% positive-predictive value (95% CI (84\u00b778% to 98\u00b711%)) and 95.83% negative-predictive value (95% CI (89\u00b794% to 98\u00b734%)). All patients used AcuPebble_SA100 correctly. Over 97% reported a strong preference for AcuPebble_SA100 over cardiorespiratory polygraphy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>These results validate the efficacy of AcuPebble_SA100 as an automated diagnosis alternative to cardiorespiratory polygraphy; also demonstrating that AcuPebble_SA100 can be used by patients without requiring human training\/assistance. This opens the doors for more efficient patient pathways for OSA diagnosis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT03544086\">NCT03544086<\/jats:ext-link>\n                      ; ClinicalTrials.gov.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-046803","type":"journal-article","created":{"date-parts":[[2021,12,21]],"date-time":"2021-12-21T12:40:32Z","timestamp":1640090432000},"page":"e046803","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":34,"title":["Accuracy and usability of AcuPebble SA100 for automated diagnosis of obstructive sleep apnoea in the home environment setting: an evaluation study"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct03544086","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Nikesh","family":"Devani","sequence":"first","affiliation":[{"name":"Thoracic Medicine, Royal Free London NHS Foundation Trust, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renard Xaviero Adhi","family":"Pramono","sequence":"additional","affiliation":[{"name":"Wearable Technologies Lab, Department of Electrical and Electronic Engineering, Imperial College of Science Technology and Medicine, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Syed Anas","family":"Imtiaz","sequence":"additional","affiliation":[{"name":"Wearable Technologies Lab, Department of Electrical and Electronic Engineering, Imperial College of Science Technology and Medicine, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stuart","family":"Bowyer","sequence":"additional","affiliation":[{"name":"Wearable Technologies Lab, Department of Electrical and Electronic Engineering, Imperial College of Science Technology and Medicine, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1957-2044","authenticated-orcid":false,"given":"Esther","family":"Rodriguez-Villegas","sequence":"additional","affiliation":[{"name":"Wearable Technologies Lab, Department of Electrical and Electronic Engineering, Imperial College of Science Technology and Medicine, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Swapna","family":"Mandal","sequence":"additional","affiliation":[{"name":"Thoracic Medicine, Royal Free London NHS Foundation Trust, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2021,12,21]]},"reference":[{"key":"2025121511412181000_11.12.e046803.1","doi-asserted-by":"crossref","first-page":"687","DOI":"10.1016\/S2213-2600(19)30198-5","article-title":"Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis","volume":"7","author":"Benjafield","year":"2019","journal-title":"Lancet Respir Med"},{"key":"2025121511412181000_11.12.e046803.2","doi-asserted-by":"crossref","first-page":"645","DOI":"10.1016\/S2213-2600(19)30226-7","article-title":"The global burden of sleep apnoea","volume":"7","author":"Grote","year":"2019","journal-title":"Lancet Respir Med"},{"key":"2025121511412181000_11.12.e046803.3","doi-asserted-by":"crossref","first-page":"185","DOI":"10.1136\/svn-2016-000038","article-title":"Sleep apnoea and stroke","volume":"1","author":"Sharma","year":"2016","journal-title":"Stroke Vasc Neurol"},{"key":"2025121511412181000_11.12.e046803.4","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.00027406"},{"key":"2025121511412181000_11.12.e046803.5","doi-asserted-by":"crossref","first-page":"244","DOI":"10.1016\/j.sleh.2017.04.003","article-title":"Sleep apnea, psychopathology, and mental health care","volume":"3","author":"Kaufmann","year":"2017","journal-title":"Sleep Health"},{"key":"2025121511412181000_11.12.e046803.6","doi-asserted-by":"crossref","first-page":"142","DOI":"10.1164\/rccm.201801-0204PP","article-title":"Obstructive sleep apnea and the risk of cognitive decline in older adults","volume":"199","author":"Gosselin","year":"2019","journal-title":"Am J Respir Crit Care Med"},{"key":"2025121511412181000_11.12.e046803.7","unstructured":"Harvard Medical School Division of Sleep Medicine . 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