NCT00001167

Brief Summary

This study will assess the use of ultrasound-a test that uses sound waves to produce images-as a diagnostic tool for evaluating speech and swallowing. The following categories of individuals may be eligible for this study: 1) healthy volunteers between 20 and 85 years old with normal speech and hearing, 2) patients 6 to 85 years old with developmental neurological deficits in speech or swallowing, and 3) patients with tumors of the oral cavity, pharynx or larynx being treated at the Greater Baltimore Medical Center. Participants will undergo a 30-minute speech and oral motion evaluation, in which they imitate sounds, words and oral movements while a speech pathologist evaluates their lip, tongue and palate movements. They may also be asked to drink a small amount of water for examination of swallowing function. For the ultrasound examination, a 3/4-inch transducer (device for transmitting and receiving sound waves) is placed under the participant's chin. While the transducer is in place, the subject 1) repeats sounds and a series of syllables in several sequences, 2) swallows three times with and without a small amount of water, and 3) swallows 3 teaspoons of non-fat pudding. The ultrasound images are recorded on tape for later analysis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
570

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 1979

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1979

Completed
20.3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
Last Updated

March 4, 2008

Status Verified

November 1, 2004

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

DysphagiaDysarthriaTongue MotionXerostomiaSwallowingSpeechPolymyositisSpeech DisordersOral-Facial ParalysisUltrasound

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Normal volunteers:
  • Normal volunteers ages 21 to 85 may be asked to participate in a study of speech and swallowing utilizing a traditional clinical examination of oral-motor performance. If the subjects are without deficits in dental occlusion, speech articulation, tongue and lip strength, tongue and lip mobility, palatal function and oral sensation they will be asked to participate in an ultrasonic evaluation of tongue/hyoid interaction during swallowing and speech.
  • Children will be included if they are referred with a medical condition that affects the oral pharyngeal phase of swallowing, voice production or laryngeal function and the investigator needs to evaluate functional performance and safety for oral feeding.
  • Neurological Group:
  • Subjects aged 6 to 85 with diagnosed developmental, neuromotor, systemic, genetic, neurologic, structural and post surgical dysfunction who have deficits in speech (dysarthria) and/or swallow (dysphagia) may be asked to participate in this study of ultrasonic imaging. Aging patients with and without dementia may also be studied. Patients with Post Polio Syndrome, Polymyositis, Dermatomyositis, Toricollis, Cerebellar Degeneration, Parkinson's disease, Progressive Supranuclear Palsy, ALS, Cystinosis, are among the conditions of interest. Subjects with complaints of oral dryness, and patients who have undergone mandibular and oral surgery may also be studied during swallowing.
  • Oropharyngeal/Laryngeal Tumors:
  • Patients will be seen who are enrolled in NCI and NIDCD protocols for head and neck tumors.

You may not qualify if:

  • Normal Subjects:
  • Hearing impairment reported (above 40 db, bilaterally)
  • Dentures
  • Oral Prosthesis
  • Palatal surgery or other restorative dental surgery
  • Radial neck dissection, glossectomy
  • Tumor or masses in neck or tongue
  • Cerebral vascular attack
  • Stuttering
  • Non-English speaker
  • Childhood articulation impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Warren G. Magnuson Clinical Center (CC)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Sonies BC, Dalakas MC. Dysphagia in patients with the post-polio syndrome. N Engl J Med. 1991 Apr 25;324(17):1162-7. doi: 10.1056/NEJM199104253241703.

    PMID: 2011159BACKGROUND
  • Sonies BC, Ekman EF, Andersson HC, Adamson MD, Kaler SG, Markello TC, Gahl WA. Swallowing dysfunction in nephropathic cystinosis. N Engl J Med. 1990 Aug 30;323(9):565-70. doi: 10.1056/NEJM199008303230903.

    PMID: 2381441BACKGROUND
  • Shawker TH, Sonies B, Hall TE, Baum BF. Ultrasound analysis of tongue, hyoid, and larynx activity during swallowing. Invest Radiol. 1984 Mar-Apr;19(2):82-6. doi: 10.1097/00004424-198403000-00003.

    PMID: 6398320BACKGROUND

MeSH Terms

Conditions

Otorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsPharyngeal NeoplasmsPolymyositisSpeech DisordersDeglutition DisordersDysarthriaXerostomiaSpeech

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesMyositisMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesArticulation DisordersSalivary Gland DiseasesMouth DiseasesVerbal BehaviorCommunicationBehavior

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

August 1, 1979

Study Completion

November 1, 2004

Last Updated

March 4, 2008

Record last verified: 2004-11

Locations