Evidence map›Paper›PMID 42312998›Full record

Trial reportJournal of speech, language, and hearing research : JSLHR2026

Optimization and Device-Level Validation of the i-Phagia Surface Electromyography Submental Sensor Patch for Swallowing Monitoring: A Randomized Crossover Design Study.

Georgia A Malandraki, Ching-Hsuan Peng, Kevin Berry, Macy Griffis, Arica Rusco, Bruce A Craig

Abstract readRandomized Controlled TrialValidation Study
In one paragraph

Trial report in Journal of speech, language, and hearing research : JSLHR, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

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

1 citing paper in PubMed.

  1. Trial
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

6 authors.

Georgia A MalandrakiDepartment of Speech, Language, and Hearing Sciences, Purdue University, West Lafayette, IN.ORCID 0000-0002-7599-7728
Ching-Hsuan PengDepartment of Speech, Language, and Hearing Sciences, Purdue University, West Lafayette, IN.
Kevin BerryDepartment of Speech, Language, and Hearing Sciences, Purdue University, West Lafayette, IN.
Macy GriffisDepartment of Speech, Language, and Hearing Sciences, Purdue University, West Lafayette, IN.
Arica RuscoDepartment of Speech, Language, and Hearing Sciences, Purdue University, West Lafayette, IN.
Bruce A CraigDepartment of Statistics, Purdue University, West Lafayette, IN.

Funding

Development and Validation of Mechanically Compliant Wearable Monitoring Systems for Swallowing Function and DisordersR21EB026099 · NIBIB · PURDUE UNIVERSITY · PI LEE, CHI HWAN, MALANDRAKI, GEORGIA · 2019 to 2021
$563k
NIBIB NIH HHS R21 EB026099
6 · The paper itself

Abstract

purposeSurface electromyography (sEMG) is a promising biofeedback method for swallowing intervention. Current sensors are either costly rigid platforms or short-lived wearables. We developed a second-generation flexible wearable sEMG patch (i-Phagia) designed to record submental muscle activity. This study validated the signal quality and preclinical performance of i-Phagia against conventional sensors in two age groups.

methodA randomized crossover study involved 30 young (17 women, 13 men; aged 18-29 years) and 30 older healthy adults (17 women, 13 men; aged 50-82 years). Participants completed liquid and semisolid swallows under two conditions: with i-Phagia sensors and with conventional sensors, in a counterbalanced order. Comparisons focused on signal-based factors (signal-to-noise ratio [SNR], baseline amplitude, and normalized mean sEMG amplitude), as well as safety, satisfaction, and placement efficiency. SNR and baseline amplitude were examined with linear mixed models and equivalence tests; Pearson correlations were used to analyze normalized mean sEMG amplitude. Safety/adverse effects were assessed with descriptive statistics, while satisfaction and efficiency were analyzed with linear mixed models.

resultsSNR values were equivalent between sensor types (effect size: -0.0178; confidence interval [CI] [-0.2226, 0.2004]); however, the i-Phagia patch showed significantly lower baseline amplitude than conventional sensors (effect size: 0.48; CI [0.3144, 0.6422]), indicating better signal quality. High correlations (

conclusionsThe optimized i-Phagia patch is safe, provides signal quality comparable to conventional sensors, and shows advantages in user satisfaction and placement efficiency. These findings support its feasibility for future clinical testing as a wearable sEMG option for swallowing rehabilitation. SUPPLEMENTAL MATERIAL: https://doi.org/10.23641/asha.32608575.

Indexed as

DeglutitionElectromyographyWearable Electronic DevicesAdolescentAdultAgedAged, 80 and overCross-Over StudiesFemaleHumansMaleMiddle AgedSignal-To-Noise RatioYoung Adult

Identifiers

PMID42312998
PMCPMC13474402

What OpenQuestion holds

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Registered trials

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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.