A new wearable diagnostic home sleep testing platform: comparison with available systems and benefits of multinight assessments

被引:2
作者
Walter, Jessica [1 ,2 ]
Lee, Jong Yoon [3 ]
Blake, Stefanida [4 ]
Kalluri, Lakshmi [4 ]
Cziraky, Mark [5 ]
Stanek, Eric [5 ]
Miller, Julie [5 ]
Harty, Brian J. [5 ]
Yu, Lian [3 ]
Park, Junbin [3 ]
Zhang, Michael [6 ]
Coughlin, Sarah [3 ]
Serao, Alexa [3 ]
Lee, Jungyup [3 ]
Buban, Alyssa [3 ]
Bae, Michelle [3 ]
Edel, Claire [6 ]
Toloui, Omid [4 ]
Rangel, Stephanie M. [6 ]
Power, Thomas [7 ]
Xu, Shuai [2 ,3 ,6 ]
机构
[1] Northwestern Univ, Feinberg Sch Med, Dept Obstet & Gynecol, Chicago, IL USA
[2] Northwestern Univ, Querrey Simpson Inst Bioelect, Chicago, IL 60611 USA
[3] Sibel Hlth, Niles, IL 60614 USA
[4] Elevance Hlth, Indianapolis, IN USA
[5] HealthCore Inc, Wilmington, DE USA
[6] Northwestern Univ Feinberg Sch Med, Northwestern Univ, Dept Dermatol, Chicago, IL 60611 USA
[7] AIM Specialty Hlth, Chicago, IL USA
来源
JOURNAL OF CLINICAL SLEEP MEDICINE | 2023年 / 19卷 / 05期
关键词
obstructive sleep apnea; home sleep apnea testing; diagnostic testing; wireless sensors; flexible electronics; patient preferences; APNEA; NIGHT; VARIABILITY; POLYSOMNOGRAPHY;
D O I
10.5664/jcsm.10432
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Study Objectives: We assessed the real-world performance of the ANNE Sleep system against 2 Food and Drug Administration-cleared home sleep testing platforms and the intraindividual night-to-night variability of respiratory event index measured by ANNE Sleep. Methods: We evaluated the home performance of the ANNE Sleep system compared with 2 Food and Drug Administration-cleared home sleep testing platforms (WatchPAT: n = 29 and Alice NightOne: n = 46) during a synchronous night with unsupervised patient application. Additionally, we evaluated night-to-night variability of respiratory event index and total sleep time using the ANNE Sleep system (n = 30). Results: For the diagnosis of moderate and severe obstructive sleep apnea, the ANNE Sleep system had a positive percent agreement of 58% (95% confidence interval, 28-85%) and a negative percent agreement of 100% (95% confidence interval, 80-100%) compared to WatchPAT. The positive and negative percent agreement for ANNE Sleep vs Alice NightOne was 85% (95% confidence interval, 66-96%) and 95% (95% confidence interval, 74-100%). There were no differences in mean total sleep time or respiratory event index across multiple nights of monitoring with ANNE. There were no differences consistent with a first-night effect but testing multiple nights reclassified obstructive sleep apnea severity in 5 (17%) individuals and detected 3 additional cases of moderate disease, with only a 12% (standard deviation, 28%) mean fluctuation in respiratory event index from the first night of testing compared to a mean of multiple nights. Overall, 80% of users found ANNE comfortable and easy to use. Conclusions: ANNE Sleep exhibited stronger concordance with Alice NightOne compared to WatchPAT. While we illustrated low night-to-night variability for ANNE Sleep, the results suggest multiple nights increased detection of moderate or severe obstructive sleep apnea. Clinical Trial Registration: Registry: ClinicalTrials.gov; Name: ANNE Diagnostic Agreement With Home Sleep Testing; URL: https://clinicaltrials.gov/ct2/show/ NCT05421754; Identifier: NCT05421754.
引用
收藏
页码:865 / 872
页数:8
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