A single-arm, open-label, multicenter, and comparative study of the ANNE sleep system vs polysomnography to diagnose obstructive sleep apnea

• Published in: Journal of clinical sleep medicine 2022-12, Vol.18 (12), p.2703-2712
• Main Authors: Davies, Charles, Lee, Jong Yoon, Walter, Jessica, Kim, Donghyun, Yu, Lian, Park, Junbin, Blake, Stefanida, Kalluri, Lakshmi, Cziraky, Mark, Stanek, Eric, Miller, Julie, Harty, Brian J, Schauer, Jacob, Rangel, Stephanie M, Serao, Alexa, Edel, Claire, Ran, Davina S, Olagbenro, Matthew O, Lim, Andrew, Gill, Kuljeet, Cooksey, Jessica, Toloui, Omid, Power, Thomas, Xu, Shuai, Zee, Phyllis
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Humans; Middle Aged; Polysomnography; Scientific Investigations; Sensitivity and Specificity; Sleep; Sleep Apnea, Obstructive - diagnosis; Young Adult
• ISSN: 1550-9389; 1550-9397
• DOI: 10.5664/jcsm.10194

Evaluate per-patient diagnostic performance of a wireless dual-sensor system (ANNE sleep) compared with reference standard polysomnography (PSG) for the diagnosis of moderate and severe obstructive sleep apnea (OSA) with a minimum prespecified threshold of 80% for both sensitivity and specificity. A multicenter clinical trial was conducted to evaluate ANNE sleep vs PSG to diagnose moderate and severe OSA in individuals 22 years or older. For each testing approach, apnea-hypopnea index (AHI) was manually scored and averaged by 3 registered sleep technologists blinded to the other system. Average variations > 15% were adjudicated by a sleep medicine physician. In a total of n = 225 participants (mean age 53 years, range 22-88 years), PSG diagnosed 30% (n = 68) of participants with moderate or severe OSA (AHI ≥ 15 events/h) compared to 29% (n = 65) diagnosed by ANNE sleep (  = .55). The sensitivity and specificity for ANNE sleep were 90% (95% confidence interval: 80-96%) and 98% (95% confidence interval: 94-99%), respectively. Strong correlation was shown in terms of final AHI (  = .93), with an average AHI bias of 0.5 (95% limits of agreement: -12.8 to 11.8). The majority of users noted comfort with using the ANNE sleep in the home setting. No adverse events were noted. Using PSG as the gold standard, ANNE sleep demonstrated high sensitivity and specificity for the diagnosis of moderate or severe OSA. Registry: ClinicalTrials.gov; Name: Comparative Study of the ANNE™ One System to Diagnose Obstructive Sleep Apnea; URL: https://clinicaltrials.gov/ct2/show/NCT04643782; Identifier: NCT04643782. Davies C, Lee JY, Walter J et al. A single-arm, open-label, multicenter, and comparative study of the ANNE sleep system vs polysomnography to diagnose obstructive sleep apnea. . 2022;18(12):2703-2712.