An interventional study of Electromyography and Maximum expiratory pressure in Healthy, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-05.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
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.
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.
University of Florida is the lead sponsor of 1,285 studies on the registry; 199 are open to participants now.
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The participants will have the following tests performed: Maximum Expiratory Pressure (MEP), insertion of a fine-wire electromyography (EMG) electrode into the mid-line base of the tongue, will complete swallowing tasks and breathing tasks under Videofluoroscopy (fluoroscopy on only during the actual task)
Procedure: Electromyography · Procedure: Maximum expiratory pressure · Procedure: Videofluoroscopy · Behavioral: Swallowing Tasks
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.
Also known as: EMG
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.
Also known as: MEP
Videofluoroscopy allows for time-synced, frame-by-frame data analysis for the specific measures taken during swallowing tasks.
Also known as: Videofluoroscopy and Barium
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.
Electromyography (EMG) will be used to analyze genioglossus muscle movement
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.
Time frame: Baseline
Kinematic Swallowing Measurements will be used to analyze a normal movement of swallowing
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.
Time frame: Baseline
Plan to share: Undecided
The record gives a start of May 2016, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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