Relationship Between Swallowing Dynamics and Suprahyoid Muscle Activity in Sarcopenic Dysphagia

Recruiting

• Conditions: Sarcopenia in Elderly; Dysphagia

• Registration Number: NCT07198568
• Lead Sponsor: Inha University Hospital

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.

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 Timeline

• Study Start: 2024-06-03
• Status Verified: 2025-09
• Study First Submitted: 2025-09-15
• Study First Submitted QC: 2025-09-21
• Last Update Submitted: 2025-09-21
• Study First Posted: 2025-09-30
• Last Update Posted: 2025-09-30
• Primary Completion: 2026-02
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amplitude of suprahyoid muscle activity: Surface electromyography data	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	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	Baseline	duration from the swallowing onset to the maximum amplitude point
Peak to onset duration of suprahyoid muscle activity: Surface electromyography data	Baseline	duration from the maximum amplitude point to the end of the swallowing

Secondary Outcome Measures

Name	Time	Method
Videofluoroscopic dysphagia scale (VDS) that assessed by Videofluoroscopic swallowing study (VFSS)	baseline	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.
Penetration aspiration scale (PAS) that assessed by Videofluoroscopic swallowing study (VFSS)	Baseline	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.
Parramatta Hospital's assessment of dysphagia that assessed by Videofluoroscopic swallowing study (VFSS)	Baseline	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
American Speech-Language-Hearing Association National Outcome Measurement System swallowing scale (ASHA NOMS scale) that assessed by Videofluoroscopic swallowing study (VFSS)	Baseline	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.

Trial Locations

Locations (1)

Inha University Hospital; 🇰🇷 Incheon, Jung-gu, South Korea