Status:
COMPLETED
Assessment of Dystussia in Traumatic Brain Injury
Lead Sponsor:
University of Florida
Collaborating Sponsors:
United States Department of Defense
Conditions:
TBI
Brain Injury
Eligibility:
All Genders
18-60 years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this research study is to evaluate coughing in people who have had a brain injury. It is hypothesized that individuals who have sustained a brain injury will demonstrate differences in ...
Detailed Description
Recovery of people with mild, moderate, or severe swallowing, speech, hearing, and cognitive-communication impairments is best facilitated by a team of multidisciplinary specialists. Symptoms associat...
Eligibility Criteria
Inclusion
- TBI within 5 years - may have accompanying neck injury but not extensive reconstruction of oral structures.
- Pulmonary function screening: FEV1 \>75%, FVC \> 75% and FEV1/FVC ratio of \>75% of age, sex and ethnicity corrected predicted values, impulse oscillometry R5 resistance measurement within 15% of age, sex and ethnicity corrected predicted values.
- Medical status permits participation.
- Cognitive status permits participation.
Exclusion
- Refuses consent.
- Cognitively incapable of informed consent
- Active substance dependence/use (from clinical interview/record review)
- Diagnosis of moderate to very severe chronic obstructive pulmonary disease (COPD; from patient interview)
- History of chronic cough and/or cough syncope (From clinical interview)
- History of cancer in the head or neck (From clinical interview)
- History of radiation to the head or neck (From clinical interview)
- History of stroke or other neurodegenerative disease (From clinical interview) Participants will be enrolled without regard for sex, ethnicity, or age.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02240329
Start Date
March 1 2013
End Date
June 1 2015
Last Update
October 28 2015
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610