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| Sponsor: | National Institute of Neurological Disorders and Stroke (NINDS) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00475943 |
Purpose
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:
| Condition |
|---|
|
Deglutition Dysphagia |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Biomechanics of Human Epiglottal Movement and Inversion |
| Estimated Enrollment: | 30 |
| Study Start Date: | May 2007 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
EXCLUSION CRITERIA:
Exclusion criteria include the following circumstances:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00475943 History of Changes |
| Other Study ID Numbers: | 070156, 07-N-0156 |
| Study First Received: | May 18, 2007 |
| Last Updated: | September 2, 2009 |
| Health Authority: | United States: Federal Government |
|
Swallowing Disorders Swallowing Videofluoroscopy Dysphagia |
Epiglottis Healthy Volunteer HV |
|
Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases |
Digestive System Diseases Pharyngeal Diseases Otorhinolaryngologic Diseases |