Evidence map›Paper›PMID 33861776›Full record

ArticlePloS one2021

Validation of a new wearable device for type 3 sleep test without flowmeter.

Mauro Contini, Antonio Sarmento, Paola Gugliandolo, Alessandra Leonardi, Gianluigi Longinotti-Buitoni, Camilla Minella, Carlo Vignati, Massimo Mapelli, Andrea Aliverti, Piergiuseppe Agostoni

Open access · goldAbstract readValidation Study
In one paragraph

Article in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.2field-weighted citation impact, top 22% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 13 citations in OpenAlex.

  1. Article
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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

10 authors at 3 institutions in 1 country.

Mauro ContiniCentro Cardiologico Monzino, IRCCS, Milano, Italy.
Antonio SarmentoDipartimento di Elettronica, Informazione e Bioingegneria, Politecnico di Milano, Milano, Italy.ORCID 0000-0001-6391-5652
Paola GugliandoloCentro Cardiologico Monzino, IRCCS, Milano, Italy.
Alessandra LeonardiL.I.F.E. Corporation S.A., Luxembourg, Luxembourg.
Gianluigi Longinotti-BuitoniL.I.F.E. Corporation S.A., Luxembourg, Luxembourg.
Camilla MinellaL.I.F.E. Italia S.r.l., Milano, Italy.
Carlo VignatiCentro Cardiologico Monzino, IRCCS, Milano, Italy.
Massimo MapelliCentro Cardiologico Monzino, IRCCS, Milano, Italy.ORCID 0000-0001-9985-7407
Andrea AlivertiDipartimento di Elettronica, Informazione e Bioingegneria, Politecnico di Milano, Milano, Italy.ORCID 0000-0002-2950-0231
Piergiuseppe AgostoniCentro Cardiologico Monzino, IRCCS, Milano, Italy.
Centro Cardiologico Monzino · ITPolitecnico di Milano · ITUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVentilation monitoring during sleep is performed by sleep test instrumentation that is uncomfortable for the patients due to the presence of the flowmeter. The objective of this study was to evaluate if an innovative type 3 wearable system, the X10X and X10Y, is able to correctly detect events of apnea and hypopnea and to classify the severity of sleep apnea without the use of a flowmeter.

methods40 patients with sleep disordered breathing were analyzed by continuous and simultaneous recording of X10X and X10Y and another certified type 3 system, SOMNOtouch, used for comparison. Evaluation was performed in terms of quality of respiratory signals (scores from 1, lowest, to 5, highest), duration and classification of apneas, as well as identification and duration of hypopneas.

results580 periods were evaluated. Mean quality assigned score was 3.37±1.42 and 3.25±1.35 for X10X and X10Y and SOMNOtouch, respectively. The agreement between the two systems was evaluated with grades 4 and 5 in 383 out of 580 cases. A high correlation (r2 = 0.921; p<0.001) was found between the AHI indexes obtained from the two systems. X10X and X10Y devices were able to correctly classify 72.3% of the obstructive apneas, 81% of the central apneas, 61.3% of the hypopneas, and 64.6% of the mixed apneas when compared to SOMNOtouch device.

conclusionThe X10X and X10Y devices are able to provide a correct grading of sleep respiratory disorders without the need of a nasal cannula for respiratory flow measurement and can be considered as a type 3 sleep test device for screening tests.

Indexed as

PolysomnographySleep Apnea SyndromesWearable Electronic DevicesAdultAgedFemaleFlowmetersHumansMaleMiddle AgedSleep

Identifiers

PMID33861776
PMCPMC8051765
OpenAlexW3152806686

What OpenQuestion holds

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Registered trials

None linked

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.