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Study of Tongue Pressures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00013832
First Posted: April 2, 2001
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose

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.


Condition
Deglutition Disorder Healthy

Study Type: Observational
Official Title: Effect of Task on Oral Pressure Dynamics During Swallowing

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):
Estimated Enrollment: 160
Study Start Date: March 28, 2001
Estimated Study Completion Date: April 11, 2007
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00013832


Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00013832     History of Changes
Other Study ID Numbers: 010135
01-CC-0135
First Submitted: March 30, 2001
First Posted: April 2, 2001
Last Update Posted: July 2, 2017
Last Verified: April 11, 2007

Keywords provided by National Institutes of Health Clinical Center (CC):
Pressure
Swallowing
Tongue
Healthy Volunteer
Dysphagia

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases