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Completed

NCT Number: NCT02687737

Tongue Motor Recruitment During Exercise

The prevalence of dysphagia may be as high as 22% in individuals over 50 years of age. There are few therapeutic options offered to these individuals. One more recent therapeutic option is Expiratory Muscle Strength Training (EMST), which has been used successfully to maintain or increase expiratory force generating pressures, cough function, and swallowing in a number of disease populations. Recently, the investigators have noted improvements in oral transit time during swallowing in individuals with Amyotrophic Lateral Sclerosis (ALS) that could potentially be attributed to improved base of tongue functioning and muscle activation.

There has been one study that demonstrated that breathing training resulted in increased and prolonged submental (under the chin) muscle activation as evidenced by surface electromyography. However, no studies have investigated the activation of the tongue muscles during various swallowing and breathing exercises. A small needle electrode (fine wire EMG) is standard of care in diagnosing muscular diseases because it can determine amount of muscle recruitment for muscles throughout the body. This aim of this research study is to examine the effects of breathing exercises and swallowing exercises on tongue muscle activity in healthy adults.

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Key information

Conditions

Healthy

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shands Hospital at the University of Florida

Gainesville, Florida, 32611, United States

About this study

This study will measure tongue muscle activation using fine wire EMG placed into the tongue muscle (underneath the chin) during swallowing and breathing exercises. A neurologist trained in EMG will perform all procedures to ensure best placement and minimize discomfort of the participant. While the needle is in place, the participant will complete a series of swallowing tasks and breathing exercises using a small, handheld training device. All swallowing and breathing tasks will be viewed under x-ray in order to see the movement and timing of the tongue and swallowing muscles during each task. Participation in the study will take one, one-hour visit to the Shands Dental Tower lab spaces where all procedures will be completed.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • No known major disease, disorder or medical conditions

Exclusion criteria

  • Currently on anticoagulant therapy
  • Has a bleeding/anticoagulant disorder or disease

Treatment and study plan

Electromyography

Procedure

During the fine wire electromyography (EMG), the participant will be asked to complete breathing exercises at 50% and 75% of their maximum capacity (determined prior to fine wire EMG using manometry) to determine activation and recruitment of genioglossus muscle.

Other names: EMG

Maximum expiratory pressure

Procedure

The participants' maximum expiratory pressure (MEP) will be assessed using a hand-held digital manometer (MP01, Micro Direct Inc.). The subject will be standing and while wearing a nose clip be asked to blow out as hard and fast as they can to determine their MEP. This will be completed a maximum of three times to obtain values within close range of one another.

Other names: MEP

Videofluoroscopy

Procedure

Videofluoroscopy allows for time-synced, frame-by-frame data analysis for the specific measures taken during swallowing tasks.

Other names: Videofluoroscopy and Barium

Swallowing Tasks

Behavioral

These include: an anterior tongue press to the alveolar ridge (behind the front molars), a saliva swallow, a 10 mL barium swallow, a 10 mL barium "hard" swallow (i.e. swallowing with extra effort), and two breathing exercise trials at 50% MEP and 75% MEP.

Primary outcomes

  1. Electromyography (EMG) will be used to analyze genioglossus muscle movement

    Time frame: Baseline

    Electromyography (EMG) activity will be recorded via standard concentric needle electrodes inserted into the genioglossus muscle. Maximum muscle activation will be recorded and analyzed to determine difference between tasks using the genioglossus muscle.

  2. Kinematic Swallowing Measurements will be used to analyze a normal movement of swallowing

    Time frame: Baseline

    Kinematic swallowing measurements is an objective analysis of videofluoroscopy. This involves capturing and manipulating digital images with computer technology to make exact timing measures of bolus flow and movement of structures, as well as spatial measurements of distance and area against reference points.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Genioglossus Motor Recruitment During Swallowing and Expiratory Loading Exercises

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 22, 2016
Registry last updated
Jan 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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