Evidence map›Paper›PMID 39773950›Full record

Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2025

Clinical validation of a wireless patch-based polysomnography system.

Christian Viniol, Wolfgang Galetke, Holger Woehrle, Georg Nilius, Christoph Schöbel, Winfried Randerath, James Leiter, Sebastian Canisius, Hartmut Schneider

Registry-linked trialAbstract readMulticenter StudyValidation StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05310708 (Validation Study of a Patch-based PSG System), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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.

NCT05310708 naunknown statusnot on this map

Validation Study of a Patch-based PSG System

TypeinterventionalSponsorOnera BVRan2022 to 2024Enrolled300ConditionsSleep DisorderArmsPolysomnography
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Validation of an artificial intelligence based single-channel photoplethysmography home sleep apnea test.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2026
    Article
  3. Article
  4. Observational
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

9 authors.

Christian ViniolDepartment of Pneumology, Universitätsklinikum Gießen und Marburg GmbH, Marburg, Germany.
Wolfgang GaletkeVAMED Klinik Hagen-Ambrock, Hagen, Germany.
Holger WoehrleLungenzentrum Ulm, Ulm, Germany.
Georg NiliusKlinikum Dortmund gGmbH, Dortmund, Germany.
Christoph SchöbelDepartment of Pneumology, Universitätsmedizin Essen Ruhrlandklinik, Essen, Germany.
Winfried RanderathKrankenhaus Bethanien, Solingen, Germany.
James LeiterDepartment of Molecular and Systems Biology, Geisel School of Medicine, Hanover, New Hampshire.
Sebastian CanisiusACliRA Consulting ApS, Tønder, Denmark.
Hartmut SchneiderAmerican Sleep Clinic, Frankfurt, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectivesOnera Health has developed the first wireless, patch-based, type-II polysomnography (PSG) system, the Onera Sleep Test System, to allow studies to be performed unattended at the patient's home or in any bed at a medical facility. The goal of this multicenter study was to validate data collected from the patch-based PSG to a traditional PSG for sleep staging and apnea-hypopnea index.

methodsSimultaneous traditional PSG and patch-based PSG study data were obtained in a sleep laboratory from 206 participants with a suspected sleep disorder recruited from 7 clinical sites. Blinded, randomized scoring of the traditional PSG and patch-based PSG recordings was completed according to

resultsConcordance correlation coefficients were high between the patch-based device and traditional PSG across essential sleep and respiratory variables-total sleep time (.87); wake (.84); non-rapid eye movement (REM) (.80); non-REM sleep stage 1 (N1) (.72); non-REM sleep stage 2 (N2) (.71); non-REM sleep stage 3 (N3) (.64); REM (.80); and apnea-hypopnea index (AHI) (.94). There was substantial agreement between epoch sleep staging scored on the patch-based device and traditional PSG (average Cohen's kappa of 0.62 ± 0.13 across all scorers).

conclusionsThe patch-based type-II PSG had a similar performance on sleep staging and respiratory variables when compared to traditional PSG, thus making it possible to use the patch-based PSG for a routine PSG study. These results open the possibility of performing unattended PSG studies efficiently and accurately outside the sleep laboratory improving access to high quality sleep assessments for patients with sleep disorders. CLINICAL

trial registrationRegistry: ClinicalTrials.gov; Name: Validation Study of a Patch-based PSG System; URL: https://clinicaltrials.gov/study/NCT05310708; Identifier: NCT05310708. CITATION: Viniol C, Galetke W, Woehrle H, et al. Clinical validation of a wireless patch-based polysomnography system.

Indexed as

PolysomnographySleep Wake DisordersWireless TechnologyAdultAgedFemaleHumansMaleMiddle AgedReproducibility of Resultshome PSGpolysomnographyrespiratory eventssleep-disordered breathingsleep staging

Identifiers

PMID39773950
PMCPMC12048320

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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.