Deglutition DisorderNCT00013832
Study of Tongue Pressures
An observational study of Deglutition Disorder and Healthy, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deglutition Disorder, Healthy
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2001to 11 Apr 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Deglutition Disorder, Healthy
- Keywords
- Pressure, Swallowing, Tongue, Healthy Volunteer, Dysphagia
- Medical subject headings
- Deglutition Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2001 (estimated)
- Study start28 Mar 2001
- Study completion11 Apr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deglutition DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00013832
- Sponsor's protocol ID
- 010135
- Other IDs
- 01-CC-0135
- Status last verified
- 11 Apr 2007
- First submitted
- 30 Mar 2001
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Chi-Fishman G, Stone M. A new application for electropalatography: swallowing. Dysphagia. 1996 Fall;11(4):239-47. doi: 10.1007/BF00265208.
PubMed 8870350
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Task on Oral Pressure Dynamics During Swallowing
- ClinicalTrials.gov ID
- NCT00013832
- Acronym / sponsor ID
- 010135
- Conditions
- Deglutition Disorder, Healthy
- Keywords
- Pressure, Swallowing, Tongue, Healthy Volunteer, Dysphagia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 28 Mar 2001
- Study completion
- 11 Apr 2007
- First posted
- 2 Apr 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- be at least 21 years of age;
Key exclusion criteria (8 listed)
- 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).
- Aspiration, as identified via the modified barium swallow study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 8870350Chi-Fishman G, Stone M. A new application for electropalatography: swallowing. Dysphagia. 1996 Fall;11(4):239-47. doi: 10.1007/BF00265208.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deglutition Disorder and Healthy, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00013832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.