Study of Tongue Pressures

Effect of Task on Oral Pressure Dynamics During Swallowing

This study will examine tongue strength and endurance, how the tongue applies pressure during swallowing, and how the chin muscles react during swallowing in healthy volunteers and in patients with dysphagia (difficulty swallowing). The information from this study may be helpful in developing better treatments for people with swallowing problems.

Healthy volunteers who have no history of speech, swallowing or breathing problems and patients who have difficulty swallowing because of a neurologic disorder, musculoskeletal disease or head and neck cancer that caused tongue weakness and dysphagia may be eligible for this study. Such medical conditions may include stroke, Parkinson's disease, multiple sclerosis corticobasal degeneration, progressive supranuclear palsy, Gaucher's disease, leukodystrophy, cerebral palsy, myositis, or mouth, throat or neck cancer. Volunteers who have not participated in a NIH protocol for 1 year will be screened with a brief medical history and physical examination. Dysphagic patients not currently enrolled in a NIH protocol will also have a brief medical history and physical examination. In addition, they will have a modified barium swallow to determine the nature and degree of their swallowing difficulty.

Participants will have a 15-minute examination of movements of their tongue, lips and jaw and will fill out a questionnaire about their swallowing ability. They will then begin the tongue pressure test. To monitor and record tongue pressure, a thin rubber strip with air-filled pressure bulbs will be attached to the roof of the mouth with dental adhesive. The pressure bulbs are connected to an external pressure-reading device. In addition, a small plastic pad with adhesive backing will be placed under the chin. Electrodes (wires) attached to the pad record chin muscle activities.

With the pressure bulbs and chin electrodes in place, the patient will perform tongue pressure tasks to test tongue strength, how long the patient can maintain a certain tongue pressure, and how fast tongue pressure drops. The tasks include saliva swallows, water swallows and cup-drinking.

Study Overview

Status

Completed

Detailed Description

The tongue enacts complex mechanical events during swallowing, the most important of which is the propulsion of a bolus from the oral cavity to the pharynx. Successful bolus transport requires the tongue to interact with other oral structures, especially the hard palate, to generate sufficient impulsive force or pressure gradients that drive the bolus toward the oropharynx. Our knowledge of deglutitive lingual pressure dynamics is at best incomplete. The available data on oral tongue pressure phenomena are based exclusively on commanded single swallows. Oral pressure changes during other important everyday eating activities (e.g., cup drinking) have not been studied to date. Past investigations revealed that rapid sequential swallowing during continuous drinking, in contrast to commanded discrete swallows, had unique tongue-palate contact patterns, surface electromyographic response characteristics, and hyoid displacement profiles. Given the different biomechanical properties and motor strategies, we hypothesize that oral lingual pressure profiles for sequential swallowing are also different, that sequential swallows require less impulsive force, and that selected dysphagic patients, especially those whose swallowing deficits are associated with reduced tongue strength, will perform sequential swallows more efficiently than they do discrete swallows. This protocol, therefore, proposes to test these hypotheses in healthy individuals of different ages, and in patients with reduced tongue strength and oral-oropharyngeal dysphagia associated with neurologic disorders, musculoskeletal diseases, or head and neck cancer. Our goals are to: (a) acquire a better and more complete understanding of normal tongue pressure phenomena as a function of swallowing tasks, (b) characterize the interrelationship between task-induced lingual pressure differences and result of clinical diagnostic tests of swallowing function in patient populations, and (c) differentially identify the profiles of dysphagic patients who can and those who cannot benefit from sequential swallowing as a compensatory/rehabilitative strategy.

Study Type

Observational

Enrollment

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:

Eligible healthy volunteers must:

  1. be at least 21 years of age;
  2. have no speech, swallowing, or respiratory problems;
  3. be in good general health;
  4. not be on medications that would adversely affect swallowing ability.

Eligible dysphagic patients must:

  1. be at least 21 years of age;
  2. have a neurologic disorder (e.g., CVA, PD, PSD, CBD, MS, Gaucher, leukodystrophy, cerebral palsy), musculoskeletal disease (e.g., polymyositis), or head and neck cancer that has caused impairments in tongue function and swallowing;
  3. present with oral or oropharyngeal dysphagia without aspiration based on results of the standard modified barium swallow study.
  4. have sufficient auditory comprehension and cognitive skills to follow test instructions and understand the nature of the study.

EXCLUSION CRITERIA:

For healthy volunteers:

  1. History of swallowing problems or other conditions that adversely affect swallowing function, tongue motility and control, hearing, language, and cognition.
  2. On medication (e.g., anticholinergics, antidepressants) that adversely affects swallowing function, tongue movement, comprehension, or cognition.
  3. Oral dryness that interferes with swallowing.
  4. Unsatisfactory performance status, as judged by the examining speech-language pathologist, that indicates poor compliance for the planned tasks (e.g., undiagnosed oral motor deficits).

For dysphagic patients:

  1. Aspiration, as identified via the modified barium swallow study.
  2. Pregnancy, as determined via a urine pregnancy test prior to the MBS test.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 28, 2001

Study Completion

April 11, 2007

Study Registration Dates

First Submitted

March 30, 2001

First Submitted That Met QC Criteria

March 30, 2001

First Posted (Estimate)

April 2, 2001

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

April 11, 2007

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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