NCT02687737

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 22, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 5, 2017

Status Verified

January 1, 2017

Enrollment Period

7 months

First QC Date

February 9, 2016

Last Update Submit

January 4, 2017

Conditions

Keywords

TongueGenioglossusgenioglossus recruitment

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline

Study Arms (1)

Exercise

EXPERIMENTAL

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: ElectromyographyProcedure: Maximum expiratory pressureProcedure: VideofluoroscopyBehavioral: Swallowing Tasks

Interventions

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
Exercise

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
Exercise

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

Also known as: Videofluoroscopy and Barium
Exercise

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.

Exercise

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No known major disease, disorder or medical conditions

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shands Hospital at the University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (2)

  • Wheeler-Hegland KM, Rosenbek JC, Sapienza CM. Submental sEMG and hyoid movement during Mendelsohn maneuver, effortful swallow, and expiratory muscle strength training. J Speech Lang Hear Res. 2008 Oct;51(5):1072-87. doi: 10.1044/1092-4388(2008/07-0016). Epub 2008 Aug 26.

    PMID: 18728114BACKGROUND
  • Trinder J, Woods M, Nicholas CL, Chan JK, Jordan AS, Semmler JG. Motor unit activity in upper airway muscles genioglossus and tensor palatini. Respir Physiol Neurobiol. 2013 Sep 15;188(3):362-9. doi: 10.1016/j.resp.2013.06.011. Epub 2013 Jun 21.

    PMID: 23797183BACKGROUND

MeSH Terms

Interventions

NeurofeedbackBarium

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, PsychologicalMetals, Alkaline EarthElementsInorganic ChemicalsMetals, HeavyMetals

Study Officials

  • Emily K Plowman, PhD, CCC-SLP

    University of Florida College of Public Health and Health Professions

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2016

First Posted

February 22, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 5, 2017

Record last verified: 2017-01

Locations