Assessment of Dystussia in Traumatic Brain Injury

Completed · Early Phase 1

Conditions studied: TBI, Brain Injury

In brief

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 cough waveform and respiratory measures compared to individuals who have not sustained a brain injury.

Key facts

Study ID: NCT02240329
Run by: University of Florida
People needed: 4
Starts: 2013-03-01
Expected to finish: 2015-06-01
Last updated by the study team: 2015-10-28

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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