Evaluation of Dysphagia by 6-chnnel Surface Electromyography

Evaluation of Dysphagia by 6-chnnel Surface Electromyography and Preliminary Study for Design 6-channel Electrical Stimulation

The natural process of aging affects a few very specific timing parameters such as swallow reaction time and hyoid one movement velocity.

Many swallow timing and bolus transit parameters appear to be unaffected by aging. We want to know the changes of kinematic variables according to the aging process.

First hypothesis: There are probably be a protection mechanism that blocks functional loss progressing to kinematic abnormality. Muscle activation sequence change (i.e duration or amplitude) of the oropharyngeal muscles play an important role.

Second hypothesis: Age-related differences in muscle activation patterns will also appear differently depending on the characteristics of swallowed food.

Study Overview

• Status: Completed
• Conditions: Deglutition Disorders

Detailed Description

Inclusion criteria

Inclusion criteria of healthy older adults : Age > 60, without dysphagia, comorbidity

Inclusion criteria of young control group

: Age < 60, without dysphagia, comorbidity

No prior history of swallowing difficulty or history of central nervous system disease, and none were taking medication that are known to affect swallowing.

Surface EMG was performed at bilateral suprahyoid, thyrohyoid, sternothyroid and pharyngeal constrictors. The latency of activation and termination was checked.

• Study Type: Observational
• Enrollment (Actual): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy participants

Description

Inclusion Criteria of old group

• Age > 60, without dysphagia, comorbidity

Inclusion Criteria of young control group

• Age < 60, without dysphagia, comorbidity

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Young normal group; normal participants below 60 years
Old normal group; normal participants above 60 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Latency	the latency of muscular activation	once at study, when patient enrolled

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration	the contractile duration of evaluated muscles	once at study, when patient enrolled

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 4, 2016
• Primary Completion (ACTUAL): November 21, 2017
• Study Completion (ACTUAL): November 21, 2017

Study Registration Dates

• First Submitted: April 2, 2018
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (ACTUAL): April 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 23, 2020
• Last Update Submitted That Met QC Criteria: July 22, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: electromyography; deglutition disorders
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: B-1604/344-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No