A single-arm, open-label, multicenter, and comparative study of the ANNE sleep system vs polysomnography to diagnose obstructive sleep apnea
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Study objectives 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.Methods 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.Results 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 (P = .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 (r = .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.Conclusions Using PSG as the gold standard, ANNE sleep demonstrated high sensitivity and specificity for the diagnosis of moderate or severe OSA.Clinical trial registration 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.Citation 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. J Clin Sleep Med. 2022;18(12):2703-2712.
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In a multicenter study of 225 patients, the ANNE sensors achieved 90% sensitivity and 98% specificity for detection of moderate and severe sleep disordered breathing compared with polysomnography.
“In a multicenter study of 225 patients, the ANNE ® sensors achieved 90% sensitivity 98% specificity for detection of moderate and severe sleep disordered breathing compared to the gold standard PSG [25].”
From Pregnancy outcomes in infertility patients diagnosed with sleep disordered breathing with wireless wearable sensors (2022) · cites this paper as [25]
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References 45 · Cited by 23
- Authors
- Davies, C., Lee, J. Y., Walter, J., Kim, D., Yu, L., Park, J., Blake, S., Kalluri, L., Cziraky, M., Stanek, E., Miller, J., Harty, B. J., Schauer, J., Rangel, S. M., Serao, A., Edel, C., Ran, D. S., Olagbenro, M. O., Lim, A., Gill, K., Cooksey, J., Toloui, O., Power, T., Xu, S., & Zee, P.
- Affiliations
- Carle Foundation Hospital (US)
- Northwestern University (US)
- Sibel (United States) (US)
- Anthem (United States) (US)
- Carelon Research (United States) (US)
- Sunnybrook Health Science Centre (CA)
- AIM Specialty Health, Chicago, Illinois
- Corresponding author
- Xu, Shuai
- ORCID
- Venue
- Journal of Clinical Sleep Medicine
- Published
- 2022-12
- Volume
- 18
- Issue
- 12
- Pages
- 2703-2712
- ISSN
- 1550-9389 (ISSN-L)
- 1550-9397
- PMC
- PMC9713912
- OpenAlex
- W4292283601
- Cited by
- 23
- References
- 45
- Citations by year
- 2026: 7 · 2025: 6 · 2024: 8 · 2023: 1 · 2022: 1
- FWCI
- 2.47
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Clinical Sleep Medicine (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (UL1TR001422)
- National Center for Advancing Translational Sciences
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (K12HD050121)
- Topics
- Health Sciences › Medicine › Physiology › Obstructive Sleep Apnea Research
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Physical Sciences › Engineering › Biomedical Engineering › Non-Invasive Vital Sign Monitoring
- Keywords
- obstructive sleep apnea, home sleep testing, polysomnography, apnea-hypopnea index, diagnostic accuracy, sensitivity and specificity
- MeSH terms
- Adult, Aged, Aged, 80 and over, Humans, Middle Aged, Sensitivity and Specificity, Sleep, Polysomnography, Sleep Apnea, Obstructive, Young Adult
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