Healthy Clinical Trial
Official title:
Effect of Task on Oral Pressure Dynamics During Swallowing
Verified date | April 11, 2007 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 160 |
Est. completion date | April 11, 2007 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility |
- 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. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institutes of Health Clinical Center (CC) |
United States,
Chi-Fishman G, Stone M. A new application for electropalatography: swallowing. Dysphagia. 1996 Fall;11(4):239-47. — View Citation
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