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

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Bibliographic Details
Title:	Optimization and Device-Level Validation of the i-Phagia Surface Electromyography Submental Sensor Patch for Swallowing Monitoring: A Randomized Crossover Design Study.
Authors:	Malandraki, Georgia A.^1,2,3 georgiam@illinois.edu, Peng, Ching-Hsuan¹, Berry, Kevin¹, Griffis, Macy¹, Rusco, Arica¹, Craig, Bruce A.⁴
Source:	Journal of Speech, Language & Hearing Research. Aug2026, Vol. 69 Issue 8, p3553-3567. 15p.
Subject Terms:	Muscle physiology, Pearson correlation (Statistics), Research funding, Patient safety, Statistical sampling, Visual analog scale, Wearable technology, Randomized controlled trials, Descriptive statistics, Electromyography, Commercial product evaluation, Crossover trials, Deglutition, Confidence intervals, Data analysis software, Patient satisfaction, Sensitivity & specificity (Statistics)
Geographic Terms:	Indiana
Abstract:	Purpose: Surface 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. Method: A 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. Results: SNR 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 (r > .7) between normalized sEMG amplitudes across swallows suggest consistent muscle activity patterns across sensors. No pain was reported; skin redness was rare but twice as common after removing conventional sensors. Satisfaction was higher (p < .0001), and application was more efficient with i-Phagia (M = 1:28 v s. 2:19, p < .05). Conclusions: The 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. [ABSTRACT FROM AUTHOR]
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Database:	Education Research Complete

Description
Abstract:	Purpose: Surface 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. Method: A 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. Results: SNR 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 (r > .7) between normalized sEMG amplitudes across swallows suggest consistent muscle activity patterns across sensors. No pain was reported; skin redness was rare but twice as common after removing conventional sensors. Satisfaction was higher (p < .0001), and application was more efficient with i-Phagia (M = 1:28 v s. 2:19, p < .05). Conclusions: The 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. [ABSTRACT FROM AUTHOR]
ISSN:	10924388
DOI:	10.1044/2026_JSLHR-25-00757