Accuracy and usability of AcuPebble SA100 for automated diagnosis of obstructive sleep apnoea in the home environment setting: an evaluation study

• Published in: BMJ open Vol. 11; no. 12; p. e046803
• Main Authors: Devani, Nikesh, Pramono, Renard Xaviero Adhi, Imtiaz, Syed Anas, Bowyer, Stuart, Rodriguez-Villegas, Esther, Mandal, Swapna
• Format: Journal Article
• Language: English
• Published: England British Medical Journal Publishing Group 21.12.2021; BMJ Publishing Group LTD; BMJ Publishing Group
• Series: Original research
• Subjects: Diagnostics; Home Environment; Humans; Medical diagnosis; Medical equipment; Predictive Value of Tests; respiratory physiology; Sensitivity and Specificity; Sensors; Sleep; Sleep apnea; Sleep Apnea, Obstructive - diagnosis; Sleep Apnea, Obstructive - therapy; sleep medicine; Smartphones; Telemedicine; United Kingdom > UK; United States > US; California; telemedicine; respiratory physiology; sleep medicine
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2020-046803

ObjectivesObstructive 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.SettingsPatients 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.Participants182 consecutive patients had been referred for OSA diagnosis in which 150 successfully completed the study.Primary outcome measuresEfficacy of AcuPebble_SA100 for automated diagnosis of moderate–severe-OSA against cardiorespiratory polygraphy (sensitivity/specificity/likelihood ratios/predictive values) and validation of usability by patients themselves in their home environment.ResultsAfter returning the systems, two expert clinicians, blinded to AcuPebble_SA100’s 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’ diagnosis with positive and negative likelihood ratios over 10 and below 0.1, respectively. Comparing against the current American Academy of Sleep Medicine’s AHI-based criteria demonstrated 95.33% accuracy (95% CI (90·62% to 98·10%)), 96.84% specificity (95% CI (91·05% to 99·34%)), 92.73% sensitivity (95% CI (82·41% to 97·98%)), 94.4% positive-predictive value (95% CI (84·78% to 98·11%)) and 95.83% negative-predictive value (95% CI (89·94% to 98·34%)). All patients used AcuPebble_SA100 correctly. Over 97% reported a strong preference for AcuPebble_SA100 over cardiorespiratory polygraphy.ConclusionsThese 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.Trial registration numberNCT03544086; ClinicalTrials.gov.