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NCT00475943 · ClinicalTrials.gov registry record
Movement of Epiglottis During Swallowing
A clinical trial of Dysphagia and Deglutition, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- 30
- Enrollment target
- 1
- Study location
NCT00475943 is a study of Dysphagia and Deglutition that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 30 participants, below the 171-participant average among 35 other Dysphagia trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00475943, a study of Dysphagia and Deglutition, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- 30 participants
- Enrollment target
- 1
- Study location
Study 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. 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
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2007-05-16 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00475943
The ClinicalTrials.gov registry entry for NCT00475943 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 171-participant average among 35 other Dysphagia trials with a reported enrollment target (82% lower). The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Dysphagia appearing as the primary indexed condition, and to 0 interventions.
NCT00475943 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00475943 about?
NCT00475943 is a clinical study titled "Movement of Epiglottis During Swallowing". 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 goa...
What is the current status of trial NCT00475943?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2007-05-16.
What conditions does trial NCT00475943 study?
This clinical trial studies the following conditions: Dysphagia, Deglutition.
Who is sponsoring clinical trial NCT00475943?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00475943 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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