Evidence map›Paper›PMID 35934926›Full record

ArticleJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2022

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

Charles Davies, Jong Yoon Lee, Jessica Walter, Donghyun Kim, Lian Yu, Junbin Park, Stefanida Blake, Lakshmi Kalluri, Mark Cziraky, Eric Stanek and 15 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter Study
In one paragraph

Article in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04643782 (A Single Arm, Open-Label, Multi-Center, and Comparative Study of the Anne Sleep System Versus Polysomnography to Diagnose Obstructive Sleep Apnea), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
2.1field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04643782 nacompletednot on this map

A Single Arm, Open-Label, Multi-Center, and Comparative Study of the Anne Sleep System Versus Polysomnography to Diagnose Obstructive Sleep Apnea: ANNE Program for the Non-Invasive Evaluation of Apnea in Sleep (APNEAs)

TypeinterventionalSponsorNorthwestern UniversityRan2021 to 2021Enrolled287ConditionsObstructive Sleep Apnea of AdultArmsANNE Sleep
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 20 citations in OpenAlex.

  1. Trial
  2. Trial
  3. A new wearable diagnostic home sleep testing platform: comparison with available systems and benefits of multinight assessments.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2023
    Trial
  4. From classic to cutting-edge: technological approaches to respiratory physiological signals in assessing sleep-disordered breathing.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2026
    Review
  5. Article
  6. Article
  7. Multidiagnostic chest-worn patch to detect obstructive sleep apnea and cardiac arrhythmias.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2025
    Article
  8. Article
  9. Review
  10. OSA diagnosis goes wearable: are the latest devices ready to shine?Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2024
    Review
  11. Article
  12. Article
  13. Article
  14. Observational
  15. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors at 7 institutions in 2 countries.

Charles DaviesCarle Neuroscience Institute, Division of Sleep Medicine, Carle Foundation Hospital, Urbana, Illinois.
Jong Yoon LeeSibel Health, Niles, Illinois.
Jessica WalterDepartment of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois.
Donghyun KimSibel Health, Niles, Illinois.
Lian YuSibel Health, Niles, Illinois.
Junbin ParkSibel Health, Niles, Illinois.
Stefanida BlakeAnthem, Inc. Elevance Health, Indianapolis, Indiana.
Lakshmi KalluriAnthem, Inc. Elevance Health, Indianapolis, Indiana.
Mark CzirakyHealthCore, Inc., Wilmington, Delaware.
Eric StanekHealthCore, Inc., Wilmington, Delaware.
Julie MillerHealthCore, Inc., Wilmington, Delaware.
Brian J HartyHealthCore, Inc., Wilmington, Delaware.
Jacob SchauerDepartment of Preventative Medicine, Northwestern University, Chicago, Illinois.
Stephanie M RangelDepartment of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Alexa SeraoDepartment of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Claire EdelDepartment of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Davina S RanDepartment of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Matthew O OlagbenroDepartment of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Andrew LimDivision of Sleep Medicine, Department of Neurology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
Kuljeet GillCentral DuPage Hospital, Northwestern Medicine, Winfield, Illinois.
Jessica CookseyDivision of Sleep Medicine, Department of Neurology, Northwestern University, Chicago, Illinois.
Omid TolouiAnthem, Inc. Elevance Health, Indianapolis, Indiana.
Thomas PowerAIM Specialty Health, Chicago, Illinois.
Shuai XuQuerrey Simpson Institute for Bioelectronics, Northwestern University, Evanston, Illinois.
Phyllis ZeeDivision of Sleep Medicine, Department of Neurology, Northwestern University, Chicago, Illinois.
Northwestern University · USWilmington University · USAnthem (United States) · USSibel (United States) · USCarle Foundation Hospital · USHealth Sciences Centre · CANorthwestern Medicine Lake Forest Hospital · US

Funding

Northwestern University Clinical and Translational Science Institute (NUCATS)UL1TR001422 · NCATS · NORTHWESTERN UNIVERSITY AT CHICAGO · PI D'AQUILA, RICHARD · 2015 to 2023
$56.8M
Research Career Development in Obstetrics and GynecologyK12HD050121 · NICHD · NORTHWESTERN UNIVERSITY AT CHICAGO · PI Serdar E. Bulun · 2005 to 2026
$7.2M
NCATS NIH HHS UL1 TR001422NICHD NIH HHS K12 HD050121
6 · The paper itself

Abstract

STUDY

objectivesEvaluate 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.

methodsA 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.

resultsIn 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 (

conclusionsUsing PSG as the gold standard, ANNE sleep demonstrated high sensitivity and specificity for the diagnosis of moderate or severe OSA. CLINICAL

trial registrationRegistry: 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.

Indexed as

Sleep Apnea, ObstructiveAdultAgedAged, 80 and overHumansMiddle AgedPolysomnographySensitivity and SpecificitySleepYoung Adultdiagnostic testingflexible electronicshome sleep apnea testingobstructive sleep apneapatient preferencespolysomnographywireless sensors

Identifiers

PMID35934926
PMCPMC9713912
OpenAlexW4292283601

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.