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| Tracking Information | |
|---|---|
| First Received Date ICMJE | March 30, 2001 |
| Last Updated Date | March 5, 2008 |
| Start Date ICMJE | March 2001 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00013832 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Study of Tongue Pressures |
| Official Title ICMJE | Effect of Task on Oral Pressure Dynamics During Swallowing |
| 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. |
| 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 Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | |
| Condition ICMJE |
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| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * | Chi-Fishman G, Stone M. A new application for electropalatography: swallowing. Dysphagia. 1996 Fall;11(4):239-47. |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 160 |
| Completion Date | April 2007 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE |
Eligible healthy volunteers must:
Eligible dysphagic patients must:
EXCLUSION CRITERIA: For healthy volunteers:
For dysphagic patients:
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| Gender | Both |
| Ages | 21 Years and older |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00013832 |
| Responsible Party | |
| Study ID Numbers ICMJE | 010135, 01-CC-0135 |
| Study Sponsor ICMJE | National Institutes of Health Clinical Center (CC) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | April 2007 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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