Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00013832
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2001-03-30
Brief Title:
Study of Tongue Pressures
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effect of Task on Oral Pressure Dynamics During Swallowing
Status:
COMPLETED
Status Verified Date:
2007-04-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Parkinsons disease multiple sclerosis corticobasal degeneration progressive supranuclear palsy Gauchers 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
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 Parkinsons disease multiple sclerosis corticobasal degeneration progressive supranuclear palsy Gauchers 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 eg 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 compensatoryrehabilitative strategy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-CC-0135 | None | None | None |