Relationship Between Swallowing Dynamics and Suprahyoid Muscle Activity in Sarcopenic Dysphagia

NCT ID: NCT07198568

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-03

Study Completion Date

2026-03-31

Brief Summary

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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

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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

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Sarcopenia in Elderly Dysphagia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Dysphagic group

-Dysphagic group: Participants with a Penetration Aspiration score (PAS) of 3 points or higher that observed by Videofluoroscopic swallowing study were considered to have dysphagia

Surface electromyography

Intervention Type DIAGNOSTIC_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)

Intervention Type 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.

Non-dysphagic group

Participants with a Penetration Aspiration score (PAS) of 2 points or lower that observed by Videofluoroscopic swallowing study

Surface electromyography

Intervention Type DIAGNOSTIC_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)

Intervention Type 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.

Interventions

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Surface electromyography

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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inha University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joa KyungLim

M.D. PhD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Inha University Hospital

Incheon, Jung-gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Moon Jung Kim

Role: CONTACT

+821055605875

Kyung Lim Joa

Role: CONTACT

Facility Contacts

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Moon Jung Kim

Role: primary

+8210-5560-5875

Kyung Lim Joa

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 33116453 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11018445 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24690326 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 10984826 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19232090 (View on PubMed)

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Reference Type BACKGROUND
PMID: 18366770 (View on PubMed)

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Reference Type BACKGROUND
PMID: 24262952 (View on PubMed)

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Reference Type BACKGROUND
PMID: 22538556 (View on PubMed)

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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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Reference Type BACKGROUND
PMID: 25548028 (View on PubMed)

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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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Other Identifiers

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2024-04-012

Identifier Type: -

Identifier Source: org_study_id

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