跳至主要内容
临床试验/NCT07198568
NCT07198568招募中不适用

Relationship Between Swallowing Dynamics and Suprahyoid Muscle Activity in Sarcopenic Dysphagia

Inha University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年6月3日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Amplitude of suprahyoid muscle activity: Surface electromyography data

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

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

干预措施: Surface electromyography (Diagnostic Test)

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

干预措施: Videofluoroscopic swallowing study (VFSS) (Diagnostic Test)

Non-aspiration group

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

干预措施: Surface electromyography (Diagnostic Test)

Non-aspiration group

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

干预措施: Videofluoroscopic swallowing study (VFSS) (Diagnostic Test)

结局指标

主要结局

Amplitude of suprahyoid muscle activity: Surface electromyography data

时间窗: 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

时间窗: 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

时间窗: Baseline

duration from the swallowing onset to the maximum amplitude point

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

时间窗: Baseline

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joa KyungLim

M.D. PhD.

Inha University Hospital

研究点 (1)

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