Sarcopenia in ElderlyNCT07198568
Relationship Between Swallowing Dynamics and Suprahyoid Muscle Activity in Sarcopenic Dysphagia
An observational study of Sarcopenia in Elderly and Dysphagia, run by Inha University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia in Elderly, Dysphagia
- What is being tested?
- Surface electromyography and Videofluoroscopic swallowing study (VFSS)
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Jun 2024to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 65 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kyung Lim Joa contact
South Korea1 site, 1 recruiting
- Recruiting
Inha University Hospital
Incheon, Jung-gu, 22332
Moon Jung Kim, +8210-5560-5875, rlaanswjd1997@gmail.com
Kyung Lim Joa
About this study
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.
Read the detailed description
Measuring the muscle activity of the suprahyoid muscles presents a challenge due to their location, which is difficult to access. Despite this difficulty, surface Electromyography (sEMG) is an effective method for assessing the electrical activity of the suprahyoid muscles. sEMG is a non-invasive, portable, and cost-effective technique that records activity within the electrode detection area. It has been suggested as a diagnostic tool for identifying dysphagia. Several studies have demonstrated that specific patterns in the sEMG of suprahyoid muscles, including duration and amplitude, exhibit distinct characteristics attributable to various etiologies.
A previous study has examined the suprahyoid muscle activity patterns in sarcopenic dysphagia patients using 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, Investigators aim to analyze the relationship between suprahyoid muscle activity patterns and swallowing dynamics utilizing these modalities.
Videofluoroscopic swallowing study (VFSS) will done for all participants to evaluate swallowing function. The VFSS procedure followed the Logemann protocol and will be supervised by a rehabilitation physician and an occupational therapist. Another physician will observe and score the test without having access to the patient's personal details.
During the VFSS, participants will seat upright in a chair, swallowing images of the lateral projection will be obtained from participants. The participants undergo swallowing trials with varying viscosities, including semiliquid, semisolid, solid, and thin liquids (2cc, 5cc, 10cc). All trials are mixed with an undiluted liquid barium solution, barium sulfate. During the procedure, participants will undergo progressively thicker food, starting from liquids and advancing to solid materials. Following the protocol, liquid 2 cubic centimeter (cc) trial will precede to the 5cc trial. If, the 2cc trial indicated aspiration and the physician determined there was a high risk for aspiration, next step of trial can be skipped and the VFSS will be stopped. If, a large amount of aspiration occurred, the VFSS will be halted, and the participant will encouraged to expectorate the food material.
The activity of suprahyoid muscles will be recorded using a surface electromyography. Pairs of disposable self-adhesive electrodes will fixed to the skin surface of the suprahyoid muscles. The electrodes positioned symmetrically between the hyoid bone and the chin, with a center-to-center distance of 20mm. Before attaching, participants will seated upright in a chair and the skin surface will be cleaned using alcohol swabs. After attaching the electrodes, participant instructed to open their jaw as wide as they could for 10 seconds to measure the amplitude, which can be used as a reference for normalization. The amplitude of sEMG is influenced by various tissue conditions. Therefore, normalization based on a reference muscle contraction is necessary to compare amplitudes between individuals. Subsequently, participants will received 2ml of water on the floor of the mouth using a syringe, and will be instructed to swallow under the guidance of a rehabilitation physician. Each participant undergo three trials of water swallowing, separated by 30 seconds intervals.
- Conditions
- Sarcopenia in Elderly, Dysphagia
- Being tested
- Surface electromyography, Videofluoroscopic swallowing study (VFSS)
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface electromyographyDiagnostic test
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.
Videofluoroscopic swallowing study (VFSS)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Surface electromyography; Diagnostic 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 Receives: Diagnostic Test: Surface electromyography; Diagnostic Test: Videofluoroscopic swallowing study (VFSS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline
Onset to peak duration of suprahyoid muscle activity: Surface electromyography data
duration from the swallowing onset to the maximum amplitude point
Measured: Baseline
Peak to onset duration of suprahyoid muscle activity: Surface electromyography data
duration from the maximum amplitude point to the end of the swallowing
Measured: Baseline
Secondary outcomes (4)
Videofluoroscopic dysphagia scale (VDS) that assessed by Videofluoroscopic swallowing study (VFSS)
VDS is 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). The scoring system of VDS ranges from 0 to 100, with up to 40 points for oral phase, and 60 points for pharyngeal phase. Higher scores correspond to more severe dysphagia.
Measured: baseline
Penetration aspiration scale (PAS) that assessed by Videofluoroscopic swallowing study (VFSS)
The Penetration-Aspiration Scale (PAS), which consists of 8 points, is used to measure the severity of airway invasion events and the patient's responses during VFSS. The scoring system of PAS ranges from 1 to 8. Higher scores correspond to more severe dysphagia.
Measured: Baseline
Parramatta Hospital's assessment of dysphagia that assessed by Videofluoroscopic swallowing study (VFSS)
The Parramatta Hospitals Assessment of Dysphagia provides a quantitative rating of swallowing. It is composed of fourteen aspects of bulbar and swallowing function (the level of alertness, respiratory function, comprehension, expression, lip, tongue, palatal motor function, gag reflex, phonation, cough, preparatory, oral and pharyngeal stages of swallowing, and tolerance for differing food consistencies). The scoring system of Parramatta Hospital's assessment of dysphagia ranges from 20 to 100. Lower scores correspond to more severe dysphagia
Measured: Baseline
American Speech-Language-Hearing Association National Outcome Measurement System swallowing scale (ASHA NOMS scale) that assessed by Videofluoroscopic swallowing study (VFSS)
The ASHA-NOMS scale assesses the functional level of swallowing. This measurement indicates the level of supervision necessary for feeding and suggests the appropriate diet type, with scores from 1 to 7. Lower scores correspond to more severe dysphagia.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start3 Jun 2024
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Sarcopenia in ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inha University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joa KyungLim, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198568
- Sponsor's protocol ID
- 2024-04-012
- Status last verified
- Mar 2026
- First submitted
- 15 Sep 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 11018445Wakabayashi 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.
PubMed 24690326Shapiro J. Evaluation and treatment of swallowing disorders. Compr Ther. 2000 Fall;26(3):203-9. doi: 10.1007/s12019-000-0010-0.
PubMed 10984826Vaiman 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.
PubMed 19232090Monaco 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.
PubMed 18366770Shaw 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.
PubMed 24262952Tamura 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.
PubMed 22538556Dellis 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.
PubMed 32300688Yoshimura 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.
PubMed 27885410Woo 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.
PubMed 25548028Palmer 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.
PubMed 30253892de 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.
PubMed 32594668Abdullah 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.
PubMed 24317386Sakai 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.
PubMed 33116453
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Swallowing Dynamics and Suprahyoid Muscle Activity in Sarcopenic Dysphagia
- ClinicalTrials.gov ID
- NCT07198568
- Acronym / sponsor ID
- 2024-04-012
- Conditions
- Sarcopenia in Elderly, Dysphagia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Inha University HospitalUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Measuring the muscle activity of the suprahyoid muscles presents a challenge due to their location, which is difficult to access. Despite this difficulty, surface Electromyography (sEMG) is an effective method for assessing the electrical activity of the suprahyoid muscles. sEMG is a non-invasive, portable, and cost-effective technique that records activity within the electrode detection area. It has been suggested as a diagnostic tool for identifying dysphagia. Several studies have demonstrated that specific patterns in the sEMG of suprahyoid muscles, including duration and amplitude, exhibit distinct characteristics attributable to various etiologies.
A previous study has examined the suprahyoid muscle activity patterns in sarcopenic dysphagia patients using 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, Investigators aim to analyze the relationship between suprahyoid muscle activity patterns and swallowing dynamics utilizing these modalities.
Videofluoroscopic swallowing study (VFSS) will done for all participants to evaluate swallowing function. The VFSS procedure followed the Logemann protocol and will be supervised by a rehabilitation physician and an occupational therapist. Another physician will observe and score the test without having access to the patient's personal details.
During the VFSS, participants will seat upright in a chair, swallowing images of the lateral projection will be obtained from participants. The participants undergo swallowing trials with varying viscosities, including semiliquid, semisolid, solid, and thin liquids (2cc, 5cc, 10cc). All trials are mixed with an undiluted liquid barium solution, barium sulfate. During the procedure, participants will undergo progressively thicker food, starting from liquids and advancing to solid materials. Following the protocol, liquid 2 cubic centimeter (cc) trial will precede to the 5cc trial. If, the 2cc trial indicated aspiration and the physician determined there was a high risk for aspiration, next step of trial can be skipped and the VFSS will be stopped. If, a large amount of aspiration occurred, the VFSS will be halted, and the participant will encouraged to expectorate the food material.
The activity of suprahyoid muscles will be recorded using a surface electromyography. Pairs of disposable self-adhesive electrodes will fixed to the skin surface of the suprahyoid muscles. The electrodes positioned symmetrically between the hyoid bone and the chin, with a center-to-center distance of 20mm. Before attaching, participants will seated upright in a chair and the skin surface will be cleaned using alcohol swabs. After attaching the electrodes, participant instructed to open their jaw as wide as they could for 10 seconds to measure the amplitude, which can be used as a reference for normalization. The amplitude of sEMG is influenced by various tissue conditions. Therefore, normalization based on a reference muscle contraction is necessary to compare amplitudes between individuals. Subsequently, participants will received 2ml of water on the floor of the mouth using a syringe, and will be instructed to swallow under the guidance of a rehabilitation physician. Each participant undergo three trials of water swallowing, separated by 30 seconds intervals.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspiration group | – | Diagnostic Test: Surface electromyography, Diagnostic Test: Videofluoroscopic swallowing study (VFSS)-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 |
| Non-aspiration group | – | Diagnostic Test: Surface electromyography, Diagnostic Test: Videofluoroscopic swallowing study (VFSS)Participants with a Penetration Aspiration score (PAS) of 5 points or lower that observed by Videofluoroscopic swallowing study |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- 65 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surface electromyographyA 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. | Diagnostic test | Aspiration group, Non-aspiration group |
| 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. 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. | Diagnostic test | Aspiration group, Non-aspiration group |
Primary outcome
Amplitude of suprahyoid muscle activity: Surface electromyography data
Time frame: Baseline
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).
Total duration of suprahyoid muscle activity: Surface electromyography data
Time frame: Baseline
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.
Onset to peak duration of suprahyoid muscle activity: Surface electromyography data
Time frame: Baseline
duration from the swallowing onset to the maximum amplitude point
Peak to onset duration of suprahyoid muscle activity: Surface electromyography data
Time frame: Baseline
duration from the maximum amplitude point to the end of the swallowing
4 secondary outcomes
Videofluoroscopic dysphagia scale (VDS) that assessed by Videofluoroscopic swallowing study (VFSS)
Time frame: baseline
Penetration aspiration scale (PAS) that assessed by Videofluoroscopic swallowing study (VFSS)
Time frame: Baseline
Parramatta Hospital's assessment of dysphagia that assessed by Videofluoroscopic swallowing study (VFSS)
Time frame: Baseline
American Speech-Language-Hearing Association National Outcome Measurement System swallowing scale (ASHA NOMS scale) that assessed by Videofluoroscopic swallowing study (VFSS)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Background: PubMed 11018445Hermens 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.
- Background: PubMed 24690326Wakabayashi 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.
- Background: PubMed 10984826Shapiro J. Evaluation and treatment of swallowing disorders. Compr Ther. 2000 Fall;26(3):203-9. doi: 10.1007/s12019-000-0010-0.
- Background: PubMed 19232090Vaiman 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.
- Background: PubMed 18366770Monaco 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.
- Background: PubMed 24262952Shaw 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.
- Background: PubMed 22538556Tamura 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.
- Background: PubMed 32300688Dellis 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.
- Background: PubMed 27885410Yoshimura 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.
- Background: PubMed 25548028Woo 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.
- Background: PubMed 30253892Palmer 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.
- Background: PubMed 32594668de 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kyung Lim Joa contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia in Elderly and Dysphagia, run by Inha University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moon Jung Kim (+821055605875, rlaanswjd1997@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude of suprahyoid muscle activity: Surface electromyography data (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07198568, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.