Trial Outcomes & Findings for Assessment of Dystussia in Traumatic Brain Injury (NCT NCT02240329)
NCT ID: NCT02240329
Last Updated: 2015-10-28
Results Overview
Following 30 seconds of tidal breathing (to allow for acclimation to the facemask), participants were instructed to "take a sharp breath in" whereupon the nebulized capsaicin solution was automatically administered by the dosimeter. Following each aerosol presentation, the participant was instructed to rate their UTC using a modified Borg Rating Scale where 1 = no UTC and 10 = maximum UTC. Between presentations, participants were given a minimum of a one-minute rest period where they were offered water. An average across all measurements was performed for the analysis.
COMPLETED
EARLY_PHASE1
4 participants
Day 1
2015-10-28
Participant Flow
Participant milestones
| Measure |
Individuals With TBI
Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.
Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.
Respiratory measures: We will collect measures of cough airflow and breathing strength.
Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is.
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|---|---|
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Overall Study
STARTED
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4
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Overall Study
Determination of Urge to Cough
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4
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Overall Study
COMPLETED
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4
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of Dystussia in Traumatic Brain Injury
Baseline characteristics by cohort
| Measure |
Individuals With TBI
n=4 Participants
Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.
Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.
Respiratory measures: We will collect measures of cough airflow and breathing strength.
Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is.
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|---|---|
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Age, Continuous
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28.38 years
STANDARD_DEVIATION 13.97 • n=5 Participants
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Sex: Female, Male
Female
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2 Participants
n=5 Participants
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Sex: Female, Male
Male
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2 Participants
n=5 Participants
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Region of Enrollment
United States
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4 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Day 1Following 30 seconds of tidal breathing (to allow for acclimation to the facemask), participants were instructed to "take a sharp breath in" whereupon the nebulized capsaicin solution was automatically administered by the dosimeter. Following each aerosol presentation, the participant was instructed to rate their UTC using a modified Borg Rating Scale where 1 = no UTC and 10 = maximum UTC. Between presentations, participants were given a minimum of a one-minute rest period where they were offered water. An average across all measurements was performed for the analysis.
Outcome measures
| Measure |
Individuals With TBI
n=4 Participants
Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.
Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.
Respiratory measures: We will collect measures of cough airflow and breathing strength.
Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is.
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|---|---|
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Average Urge to Cough (UTC) Following Administration of 200 Micro Mole Capsaicin Solution Concentration
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4.5 Units on a Borg scale
Standard Error 1.68
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PRIMARY outcome
Timeframe: Day 1The total cough count (CTot) was determined by counting all cough events that occurred following each presentation of capsaicin solution. CTot was made, in real time, by two investigators and confirmed via review of the recorded cough airflow signal. Capsaicin concentration necessary to elicit a two cough threshold response (C2) within 30 seconds of presentation, on at least two (out of three) trials of that concentration, was identified from the cough count record. An average across all measurements was performed for the analysis.
Outcome measures
| Measure |
Individuals With TBI
n=4 Participants
Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.
Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.
Respiratory measures: We will collect measures of cough airflow and breathing strength.
Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is.
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|---|---|
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Number of Coughs in Response to Stimulation With 200 Micro Moles Capsaicin in Solution
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2.83 cough events following stimulation
Standard Deviation 0.43
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Adverse Events
Individuals With TBI
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place