NCT07198568

Brief Summary

Sarcopenic dysphagia is defined as swallowing difficulty among the elderly due to the loss of whole body skeletal and swallowing muscle mass and function. However, the pathophysiology and dynamics of swallowing in sarcopenic dysphagia have been poorly investigated. Therefore, the present study aims to investigate the characteristics of sarcopenic dysphagia using the Videofluoroscopic study (VFSS) focusing on each phase of dysphagia, and surface Electromyography (surface EMG) to assess suprahyoid muscle activity. In sarcopenic dysphagia, impairments will occur in both the oral and pharyngeal phases, particularly affecting bolus formation, premature bolus spillage and laryngeal elevation during swallowing due to the loss of swallowing muscle mass and function. These changes will be considered to have led to an change of duration and amplitude of suprahyoid muscle activity measured via surface EMG.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 30, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

September 15, 2025

Last Update Submit

March 4, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Amplitude of suprahyoid muscle activity: Surface electromyography data

    The measurement parameters included the mean and maximum amplitudes of suprahyoid muscle activation during swallowing. Amplitude values were normalized relative to the amplitude observed during jaw opening contraction (JOC). Both mean and maximum amplitudes were subsequently expressed as percentages of the jaw opening contraction (%JOC).

    Baseline

  • Total duration of suprahyoid muscle activity: Surface electromyography data

    The onset of swallowing was defined as the point at which a distinct visual increase in sEMG activity above the background level was observed and the end point of swallowing was determined as the moment when the sEMG trace returned to within +2 standard deviations (SDs) of the baseline amplitude level. The baseline amplitude was calculated as the average amplitude during a 1 second period at rest from the start of the sEMG trace.

    Baseline

  • Onset to peak duration of suprahyoid muscle activity: Surface electromyography data

    duration from the swallowing onset to the maximum amplitude point

    Baseline

  • Peak to onset duration of suprahyoid muscle activity: Surface electromyography data

    duration from the maximum amplitude point to the end of the swallowing

    Baseline

Secondary Outcomes (4)

  • Videofluoroscopic dysphagia scale (VDS) that assessed by Videofluoroscopic swallowing study (VFSS)

    baseline

  • Penetration aspiration scale (PAS) that assessed by Videofluoroscopic swallowing study (VFSS)

    Baseline

  • Parramatta Hospital's assessment of dysphagia that assessed by Videofluoroscopic swallowing study (VFSS)

    Baseline

  • American Speech-Language-Hearing Association National Outcome Measurement System swallowing scale (ASHA NOMS scale) that assessed by Videofluoroscopic swallowing study (VFSS)

    Baseline

Study Arms (2)

Aspiration group

-Dysphagic group: Participants with a Penetration Aspiration score (PAS) of 6 points or higher that observed by Videofluoroscopic swallowing study were considered to have dysphagia

Diagnostic Test: Surface electromyographyDiagnostic Test: Videofluoroscopic swallowing study (VFSS)

Non-aspiration group

Participants with a Penetration Aspiration score (PAS) of 5 points or lower that observed by Videofluoroscopic swallowing study

Diagnostic Test: Surface electromyographyDiagnostic Test: Videofluoroscopic swallowing study (VFSS)

Interventions

A previous other study has examined the suprahyoid muscle activity patterns in sarcopenic dysphagia patients using surface electromyography (sEMG). However, there was a lack of research analyzing the swallowing dynamics of sarcopenic dysphagia alongside Videofluoroscopic Swallowing Study (VFSS). VFSS enables the observation of swallowing in phases, offering a crucial method for assessing the presence of dysphagia and identifying the specific phases where dysphagia occurs. Therefore, the present study aims to investigate the characteristics of sarcopenic dysphagia across phases using sEMG and VFSS. Additionally, the investigators aim to analyze the relationship between suprahyoid muscle activity patterns and swallowing dynamics utilizing these modalities.

Aspiration groupNon-aspiration group

VFSS enables the observation of swallowing in phases, offering a crucial method for assessing the presence of dysphagia and identifying the specific phases where dysphagia occurs. The investigators will utilize Videofluoroscopic Dysphagia Scale (VDS), that composed of fourteen categories, which can be divided into oral and pharyngeal phases to assess scores based on VFSS results. The oral phase composed of 7 items (lip closure, bolus formation, mastication, apraxia, tongue-to-palate contact, premature bolus loss, and oral transit time). The pharyngeal phase also included 7 items (triggering of pharyngeal swallowing, vallecular residues, pyriform sinus residues, laryngeal elevation, coating of pharyngeal wall, pharyngeal transit time, and aspiration). VDS can assess the components of dysphagia in such detail. Therefore, investigators can evaluate the etiology of dysphagia more precisely.

Aspiration groupNon-aspiration group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted at an Inha University Hospital, tertial general hospital in Republic of Korea and referred to the department of physical and rehabilitation medicine to evaluate for presence of dysphagia and meet the inclusion criteria specified above.

You may qualify if:

  • years of age or older who underwent VFSS to evaluate the presence of dysphagia
  • Patient who diagnosed with sarcopenia based on the cutoff values of the Asian Working Group for Sarcopenia (AWGS) 2019
  • Cognitive ability to follow instructions for Videofluoroscopic swallowing study, surface electromyography.

You may not qualify if:

  • History of cerebral hemorrhage or cerebral infarction
  • History of neuromuscular diseases that could lead to dysphagia such as Parkinson's disease, amyotrophic lateral sclerosis, Guillain-Barre disease
  • History of Tracheostomy
  • History of oropharyngeal cancer
  • History of esophageal structural disease that could lead to dysphagia
  • History of connective tissue disease
  • History of cervical surgical procedure
  • Cognitive impairment who cannot follow instructions for Videofluoroscopic swallowing study, surface electromyography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inha University Hospital

Incheon, Jung-gu, 22332, South Korea

RECRUITING

Related Publications (14)

  • Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000 Oct;10(5):361-74. doi: 10.1016/s1050-6411(00)00027-4.

    PMID: 11018445BACKGROUND
  • Wakabayashi H, Sashika H, Matsushima M. Head lifting strength is associated with dysphagia and malnutrition in frail older adults. Geriatr Gerontol Int. 2015 Apr;15(4):410-6. doi: 10.1111/ggi.12283. Epub 2014 Apr 1.

    PMID: 24690326BACKGROUND
  • Shapiro J. Evaluation and treatment of swallowing disorders. Compr Ther. 2000 Fall;26(3):203-9. doi: 10.1007/s12019-000-0010-0.

    PMID: 10984826BACKGROUND
  • Vaiman M, Eviatar E. Surface electromyography as a screening method for evaluation of dysphagia and odynophagia. Head Face Med. 2009 Feb 20;5:9. doi: 10.1186/1746-160X-5-9.

    PMID: 19232090BACKGROUND
  • Monaco A, Cattaneo R, Spadaro A, Giannoni M. Surface electromyography pattern of human swallowing. BMC Oral Health. 2008 Mar 26;8:6. doi: 10.1186/1472-6831-8-6.

    PMID: 18366770BACKGROUND
  • Shaw SM, Martino R. The normal swallow: muscular and neurophysiological control. Otolaryngol Clin North Am. 2013 Dec;46(6):937-56. doi: 10.1016/j.otc.2013.09.006. Epub 2013 Oct 23.

    PMID: 24262952BACKGROUND
  • Tamura F, Kikutani T, Tohara T, Yoshida M, Yaegaki K. Tongue thickness relates to nutritional status in the elderly. Dysphagia. 2012 Dec;27(4):556-61. doi: 10.1007/s00455-012-9407-z. Epub 2012 Apr 27.

    PMID: 22538556BACKGROUND
  • Dellis S, Papadopoulou S, Krikonis K, Zigras F. Sarcopenic Dysphagia. A Narrative Review. J Frailty Sarcopenia Falls. 2018 Mar 1;3(1):1-7. doi: 10.22540/JFSF-03-001. eCollection 2018 Mar.

    PMID: 32300688BACKGROUND
  • Yoshimura N, Muraki S, Oka H, Iidaka T, Kodama R, Kawaguchi H, Nakamura K, Tanaka S, Akune T. Is osteoporosis a predictor for future sarcopenia or vice versa? Four-year observations between the second and third ROAD study surveys. Osteoporos Int. 2017 Jan;28(1):189-199. doi: 10.1007/s00198-016-3823-0. Epub 2016 Nov 24.

    PMID: 27885410BACKGROUND
  • Woo J, Leung J, Morley JE. Defining sarcopenia in terms of incident adverse outcomes. J Am Med Dir Assoc. 2015 Mar;16(3):247-52. doi: 10.1016/j.jamda.2014.11.013. Epub 2014 Dec 23.

    PMID: 25548028BACKGROUND
  • Palmer K, Onder G, Cesari M. The geriatric condition of frailty. Eur J Intern Med. 2018 Oct;56:1-2. doi: 10.1016/j.ejim.2018.09.011. Epub 2018 Sep 22. No abstract available.

    PMID: 30253892BACKGROUND
  • de Sire A, Giachero A, DE Santi S, Inglese K, Solaro C. Screening dysphagia risk in 534 older patients undergoing rehabilitation after total joint replacement: a cross-sectional study. Eur J Phys Rehabil Med. 2021 Feb;57(1):131-136. doi: 10.23736/S1973-9087.20.06321-2. Epub 2020 Jun 26.

    PMID: 32594668BACKGROUND
  • Abdullah B, Wolbring G. Analysis of newspaper coverage of active aging through the lens of the 2002 World Health Organization Active Ageing Report: A Policy Framework and the 2010 Toronto Charter for Physical Activity: A Global Call for Action. Int J Environ Res Public Health. 2013 Dec 5;10(12):6799-819. doi: 10.3390/ijerph10126799.

    PMID: 24317386BACKGROUND
  • Sakai K, Nakayama E, Rogus-Pulia N, Takehisa T, Takehisa Y, Urayama KY, Takahashi O. Submental Muscle Activity and Its Role in Diagnosing Sarcopenic Dysphagia. Clin Interv Aging. 2020 Oct 21;15:1991-1999. doi: 10.2147/CIA.S278793. eCollection 2020.

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Electromyography

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

ElectrodiagnosisDiagnostic Techniques and ProceduresDiagnosisMyography

Central Study Contacts

Kyung Lim Joa

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. PhD.

Study Record Dates

First Submitted

September 15, 2025

First Posted

September 30, 2025

Study Start

June 3, 2024

Primary Completion

March 1, 2026

Study Completion

April 1, 2026

Last Updated

March 6, 2026

Record last verified: 2026-03

Locations