Study of Tongue Pressures
Effect of Task on Oral Pressure Dynamics During Swallowing
2 other identifiers
observational
160
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2001
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 28, 2001
CompletedFirst Submitted
Initial submission to the registry
March 30, 2001
CompletedFirst Posted
Study publicly available on registry
April 2, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
April 11, 2007
CompletedJuly 2, 2017
April 11, 2007
March 30, 2001
June 30, 2017
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Eligible healthy volunteers must:
- be at least 21 years of age;
- have no speech, swallowing, or respiratory problems;
- be in good general health;
- not be on medications that would adversely affect swallowing ability.
- Eligible dysphagic patients must:
- be at least 21 years of age;
- 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;
- present with oral or oropharyngeal dysphagia without aspiration based on results of the standard modified barium swallow study.
- have sufficient auditory comprehension and cognitive skills to follow test instructions and understand the nature of the study.
You may not qualify if:
- For healthy volunteers:
- History of swallowing problems or other conditions that adversely affect swallowing function, tongue motility and control, hearing, language, and cognition.
- On medication (e.g., anticholinergics, antidepressants) that adversely affects swallowing function, tongue movement, comprehension, or cognition.
- Oral dryness that interferes with swallowing.
- 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:
- Aspiration, as identified via the modified barium swallow study.
- Pregnancy, as determined via a urine pregnancy test prior to the MBS test.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Related Publications (1)
Chi-Fishman G, Stone M. A new application for electropalatography: swallowing. Dysphagia. 1996 Fall;11(4):239-47. doi: 10.1007/BF00265208.
PMID: 8870350BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
March 30, 2001
First Posted
April 2, 2001
Study Start
March 28, 2001
Study Completion
April 11, 2007
Last Updated
July 2, 2017
Record last verified: 2007-04-11