DeglutitionNCT00475943
Movement of Epiglottis During Swallowing
An observational study of Deglutition and Dysphagia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will examine how the airway closes during swallowing to prevent food or liquid from entering the voice box or lungs while eating or drinking. It will also test whether electrical stimulation of muscles in the neck can close the airway as it would close during swallowing. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Deglutition, Dysphagia
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2007to 1 Sep 2009
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Included subjects will be healthy adults age 18-65 years with normal swallowing function, as determined with a medical history and physical examination by an otolaryngologist.
Who cannot join
- Subjects must not have a history of chronic swallowing difficulty or dysfunction.
- Pregnant volunteers will be excluded due to risks associated with radiation exposure.
- Women who are nursing will be excluded.
- Subjects must not currently be suffering from a psychiatric disorder other than depression, as evidenced by being under the care of a psychiatrist, or on medications for treatment of a psychiatric disorder.
- History of brain injury or neurological disease.
- History of epileptic seizure.
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- History of Rheumatic fever, mitral valve prolapse, heart murmurs, or cardiac arrhythmias as determined by medical history, physical and EKG will disqualify a subject.
- Subjects must not be taking any medications, including herbal types that can affect coagulation.
- Subjects will be excluded if they have a history of allergies to lidocaine or any other anesthetic medication.
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: Biomechanics of Human Epiglottal Movement and Inversion
This study will examine how the airway closes during swallowing to prevent food or liquid from entering the voice box or lungs while eating or drinking. It will also test whether electrical stimulation of muscles in the neck can close the airway as it would close during swallowing. The long-term goal of this research is to determine the feasibility of a new approach for helping patients with a severe and life threatening swallowing disorder.
Healthy normal volunteers between 18 and 65 years of age who can swallow normally may be eligible for this study. Candidates are screened with a medical history, physical examination, electrocardiogram and nasolaryngoscopy. For the nasolaryngoscopy, the subject's voice box and epiglottis (flap of tissue that covers the windpipe during swallowing) are examined using a thin flexible tube with a camera attached that is passed through the nose to the back of the throat. During the test, speech and other tasks such as singing and whistling are observed. The camera records the movement of the vocal cords on videotape. This procedure may be repeated another time during the study.
Read more
Participants undergo the following procedures:
- Electrical stimulation of muscles in the neck: The muscles in the neck are stimulated with brief low-level electrical currents to see if the stimulation can cause the epiglottis to fold down over the windpipe. Stimulation may be increased to a level where it feels like a small shock The subject is asked to try to do the muscle stimulation while swallowing.
- Videofluoroscopy (recording swallowing and muscle stimulation during x-ray imaging of the head): The head and neck are x-rayed while the subject swallows. After the wires have been inserted for EMG (see below), markers are glued to the tongue and a tube is inserted through the nose into the esophagus. The movements during swallowing with and without muscle stimulation are x-rayed and analyzed later to determine how the stimulation affects the movement of the epiglottis.
- Electromyography (EMG): Measurement of the electrical activity of muscles in the neck using fine wires placed through the skin into muscles in the chin.
- Manometry: During the videofluoroscopy, a manometer (tube that measures pressures) is placed through the nose and into the back of the throat at the entry point to the esophagus. This test shows whether muscle stimulation can fold down the epiglottis.
- Surface electromyography (sEMG): The tube used during the videofluoroscopy has small rings embedded in it that measure muscle activity on the surface of the inside of the throat.
Read the detailed description
OBJECTIVE:
Our objective is to determine the factors that cause epiglottic inversion during normal deglutition and attempt to recreate this movement by means of muscle stimulation.
STUDY POPULATION:
We plan to accrue 30 healthy volunteers so that a set of 20 participants will provide reliable data for analysis.
DESIGN:
As an observational study, anatomical movement will be examined with videofluoroscopy during normal swallows and during stimulation of the thyrohyoid, geniohyoid, hyoglossus, and styloglossus muscles.
OUTCOME MEASURES:
The principal outcome of this study is the distance of epiglottal displacement as measured from videofluoroscopic images during normal swallowing and muscle stimulation. Secondary measures are assessed as correlates of epiglottal inversion. These data include motion and kinematics of other structures, such as the hyo-laryngeal complex and the tongue; tongue base retraction pressures in the oral-pharynx, the hypopharynx, and the UES; and muscle activity as measured by surface electromyography in these three locations.
- Conditions
- Deglutition, Dysphagia
- Keywords
- Swallowing Disorders, Swallowing, Videofluoroscopy, Dysphagia, Epiglottis, Healthy Volunteer, HV
- 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 posted21 May 2007 (estimated)
- Study start16 May 2007
- Primary completion1 Sep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DeglutitionStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 30 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475943
- Sponsor's protocol ID
- 070156
- Other IDs
- 07-N-0156
- Status last verified
- 1 Sep 2009
- First submitted
- 18 May 2007
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Gresham SL. Clinical assessment and management of swallowing difficulties after stroke. Med J Aust. 1990 Oct 1;153(7):397-9. doi: 10.5694/j.1326-5377.1990.tb125497.x.
PubMed 2215310DOTY RW, BOSMA JF. An electromyographic analysis of reflex deglutition. J Neurophysiol. 1956 Jan;19(1):44-60. doi: 10.1152/jn.1956.19.1.44. No abstract available.
PubMed 13286721Logemann JA, Kahrilas PJ, Cheng J, Pauloski BR, Gibbons PJ, Rademaker AW, Lin S. Closure mechanisms of laryngeal vestibule during swallow. Am J Physiol. 1992 Feb;262(2 Pt 1):G338-44. doi: 10.1152/ajpgi.1992.262.2.G338.
PubMed 1539666
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
- Biomechanics of Human Epiglottal Movement and Inversion
- ClinicalTrials.gov ID
- NCT00475943
- Acronym / sponsor ID
- 070156
- Conditions
- Deglutition, Dysphagia
- Keywords
- Swallowing Disorders, Swallowing, Videofluoroscopy, Dysphagia, Epiglottis, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 16 May 2007
- Primary completion
- 1 Sep 2009 (actual)
- First posted
- 21 May 2007 (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 how the airway closes during swallowing to prevent food or liquid from entering the voice box or lungs while eating or drinking. It will also test whether electrical stimulation of muscles in the neck can close the airway as it would close during swallowing. The long-term goal of this research is to determine the feasibility of a new approach for helping patients with a severe and life threatening swallowing disorder.
Healthy normal volunteers between 18 and 65 years of age who can swallow normally may be eligible for this study. Candidates are screened with a medical history, physical examination, electrocardiogram and nasolaryngoscopy. For the nasolaryngoscopy, the subject's voice box and epiglottis (flap of tissue that covers the windpipe during swallowing) are examined using a thin flexible tube with a camera attached that is passed through the nose to the back of the throat. During the test, speech and other tasks such as singing and whistling are observed. The camera records the movement of the vocal cords on videotape. This procedure may be repeated another time during the study.
Participants undergo the following procedures:
- Electrical stimulation of muscles in the neck: The muscles in the neck are stimulated with brief low-level electrical currents to see if the stimulation can cause the epiglottis to fold down over the windpipe. Stimulation may be increased to a level where it feels like a small shock The subject is asked to try to do the muscle stimulation while swallowing.
- Videofluoroscopy (recording swallowing and muscle stimulation during x-ray imaging of the head): The head and neck are x-rayed while the subject swallows. After the wires have been inserted for EMG (see below), markers are glued to the tongue and a tube is inserted through the nose into the esophagus. The movements during swallowing with and without muscle stimulation are x-rayed and analyzed later to determine how the stimulation affects the movement of the epiglottis.
- Electromyography (EMG): Measurement of the electrical activity of muscles in the neck using fine wires placed through the skin into muscles in the chin.
- Manometry: During the videofluoroscopy, a manometer (tube that measures pressures) is placed through the nose and into the back of the throat at the entry point to the esophagus. This test shows whether muscle stimulation can fold down the epiglottis.
- Surface electromyography (sEMG): The tube used during the videofluoroscopy has small rings embedded in it that measure muscle activity on the surface of the inside of the throat.
Detailed description
OBJECTIVE:
Our objective is to determine the factors that cause epiglottic inversion during normal deglutition and attempt to recreate this movement by means of muscle stimulation.
STUDY POPULATION:
We plan to accrue 30 healthy volunteers so that a set of 20 participants will provide reliable data for analysis.
DESIGN:
As an observational study, anatomical movement will be examined with videofluoroscopy during normal swallows and during stimulation of the thyrohyoid, geniohyoid, hyoglossus, and styloglossus muscles.
OUTCOME MEASURES:
The principal outcome of this study is the distance of epiglottal displacement as measured from videofluoroscopic images during normal swallowing and muscle stimulation. Secondary measures are assessed as correlates of epiglottal inversion. These data include motion and kinematics of other structures, such as the hyo-laryngeal complex and the tongue; tongue base retraction pressures in the oral-pharynx, the hypopharynx, and the UES; and muscle activity as measured by surface electromyography in these three locations.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Included subjects will be healthy adults age 18-65 years with normal swallowing function, as determined with a medical history and physical examination by an otolaryngologist.
Key exclusion criteria (9 listed)
- Subjects must not have a history of chronic swallowing difficulty or dysfunction.
- Pregnant volunteers will be excluded due to risks associated with radiation exposure.
- Women who are nursing will be excluded.
- Subjects must not currently be suffering from a psychiatric disorder other than depression, as evidenced by being under the care of a psychiatrist, or on medications for treatment of a psychiatric disorder.
- History of brain injury or neurological disease.
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 2215310Gresham SL. Clinical assessment and management of swallowing difficulties after stroke. Med J Aust. 1990 Oct 1;153(7):397-9. doi: 10.5694/j.1326-5377.1990.tb125497.x.
- Background: PubMed 13286721DOTY RW, BOSMA JF. An electromyographic analysis of reflex deglutition. J Neurophysiol. 1956 Jan;19(1):44-60. doi: 10.1152/jn.1956.19.1.44. No abstract available.
- Background: PubMed 1539666Logemann JA, Kahrilas PJ, Cheng J, Pauloski BR, Gibbons PJ, Rademaker AW, Lin S. Closure mechanisms of laryngeal vestibule during swallow. Am J Physiol. 1992 Feb;262(2 Pt 1):G338-44. doi: 10.1152/ajpgi.1992.262.2.G338.
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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 and Dysphagia, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 1 inclusion and 9 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 NCT00475943, which also lists 3 linked publications.
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.