- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00013832
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
Conditions
Detailed Description
Study Type
Enrollment
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
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.
EXCLUSION CRITERIA:
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.
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 010135
- 01-CC-0135
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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