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

Autor:	Charles, Davies, Jong Yoon, Lee, Jessica, Walter, Donghyun, Kim, Lian, Yu, Junbin, Park, Stefanida, Blake, Lakshmi, Kalluri, Mark, Cziraky, Eric, Stanek, Julie, Miller, Brian J, Harty, Jacob, Schauer, Stephanie M, Rangel, Alexa, Serao, Claire, Edel, Davina S, Ran, Matthew O, Olagbenro, Andrew, Lim, Kuljeet, Gill, Jessica, Cooksey, Omid, Toloui, Thomas, Power, Shuai, Xu, Phyllis, Zee
Rok vydání:	2022
Předmět:	Adult Aged 80 and over Pulmonary and Respiratory Medicine Young Adult Sleep Apnea Obstructive Neurology Polysomnography Humans Neurology (clinical) Middle Aged Sleep Sensitivity and Specificity Aged
Zdroj:	Journal of Clinical Sleep Medicine. 18:2703-2712
ISSN:	1550-9397 1550-9389
DOI:	10.5664/jcsm.10194
Popis:	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 variations15% 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 (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.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::31113c847b2df28de9d1cb77ff3ed0b0 https://doi.org/10.5664/jcsm.10194 Zobrazit plný text záznamu