Clinical trial: Study of Tongue Pressures (NCT00013832)

Eligibility criteria:
-  INCLUSION CRITERIA:

        Eligible healthy volunteers must:

          1. be at least 21 years of age;

          2. have no speech, swallowing, or respiratory problems;

          3. be in good general health;

          4. not be on medications that would adversely affect swallowing ability.

        Eligible dysphagic patients must:

          1. be at least 21 years of age;

          2. 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;

          3. present with oral or oropharyngeal dysphagia without aspiration based on results of
             the standard modified barium swallow study.

          4. have sufficient auditory comprehension and cognitive skills to follow test
             instructions and understand the nature of the study.

        EXCLUSION CRITERIA:

        For healthy volunteers:

          1. History of swallowing problems or other conditions that adversely affect swallowing
             function, tongue motility and control, hearing, language, and cognition.

          2. On medication (e.g., anticholinergics, antidepressants) that adversely affects
             swallowing function, tongue movement, comprehension, or cognition.

          3. Oral dryness that interferes with swallowing.

          4. 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:

          1. Aspiration, as identified via the modified barium swallow study.

          2. Pregnancy, as determined via a urine pregnancy test prior to the MBS test.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.


Patient description (medical language): A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough.  Her other medical problems include hypertension, dyslipidemia, and osteoarthritis.  She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg.  The patient's breath smells bad. Other physical examinations are normal.  A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus.

Patient description (patient's own words): I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus.

Does the patient match the trial criteria? Contradiction