Trial Outcomes & Findings for Normal Breathing and Swallowing in Healthy Volunteers (NCT NCT03122145)
NCT ID: NCT03122145
Last Updated: 2021-01-14
Results Overview
Reflexive cough testing will use a capsaicin challenge that will assess individual's cough motor and cough sensory thresholds. A modified Borg scale ranging from 0 (no cough) to 10 (maximal urge to cough) will be used to quantify these thresholds. A cough sensory threshold will be defined as a concentration of capsaicin eliciting a perceived urge to cough of 1 (very slight) \>2/3 trials. A cough motor threshold will be the lowest concentration of capsaicin eliciting \>2 cough responses in 2/3 trials.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
49 participants
Primary outcome timeframe
Single assessment time period
Results posted on
2021-01-14
Participant Flow
2018-2019 HealthStreet university approved flyers
Experiment #1: single 60 minute visit with multiple assessments of cough and respiratory function. Experiment #2: single 60-minute visit with an instrumental swallowing evaluation (videofluoroscopy).
Participant milestones
| Measure |
Healthy Volunteers - Experiment #1
This study will involve a single 60-minute visit where healthy, eligible participants will then undergo testing to determine their individualized voluntary and reflexive cough testing. The participant will be free to leave at any point during the examination.
Capsaicin: Participants will inspire deeply through the nebulizer coupled to the facemask and pneumotachograph. Each test inhalation will be separated by an interval of 2 minutes. This experimental trial consists of six test solutions: 0, 25, 50, 100, 200 and 500 μM capsaicin in 80% physiological saline, 20% ethanol. Participants will inhale single vital capacity breaths of capsaicin solution via an air-powered dosimeter (KoKoDigidoser).
|
Healthy Volunteers - Experiment #2
This study will involve a single 60-minute visit eligible participants will then undergo an instrumental swallowing evaluation (videofluoroscopy). All women under the age of 62 will be asked to complete a pregnancy test as part of the screening process prior to radiation exposure. The entire duration of the exam will be under 60 minutes and the participant will be free to leave at any point during the examination.
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|---|---|---|
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Overall Study
STARTED
|
37
|
12
|
|
Overall Study
COMPLETED
|
34
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Healthy Volunteers - Experiment #1
This study will involve a single 60-minute visit where healthy, eligible participants will then undergo testing to determine their individualized voluntary and reflexive cough testing. The participant will be free to leave at any point during the examination.
Capsaicin: Participants will inspire deeply through the nebulizer coupled to the facemask and pneumotachograph. Each test inhalation will be separated by an interval of 2 minutes. This experimental trial consists of six test solutions: 0, 25, 50, 100, 200 and 500 μM capsaicin in 80% physiological saline, 20% ethanol. Participants will inhale single vital capacity breaths of capsaicin solution via an air-powered dosimeter (KoKoDigidoser).
|
Healthy Volunteers - Experiment #2
This study will involve a single 60-minute visit eligible participants will then undergo an instrumental swallowing evaluation (videofluoroscopy). All women under the age of 62 will be asked to complete a pregnancy test as part of the screening process prior to radiation exposure. The entire duration of the exam will be under 60 minutes and the participant will be free to leave at any point during the examination.
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|---|---|---|
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Overall Study
Concurrent respiratory disease
|
3
|
0
|
Baseline Characteristics
Normal Breathing and Swallowing in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Healthy Volunteers - Experiment #1
n=34 Participants
This study will involve a single 60-minute visit where healthy, eligible participants will undergo testing to determine their individualized voluntary and reflexive cough testing. The participant will be free to leave at any point during the examination.
|
Healthy Volunteers - Experiment #2
n=12 Participants
This study will involve a single 60-minute visit where healthy, eligible participants will undergo an instrumental swallowing evaluation (videofluoroscopy). All women under the age of 62 will be asked to complete a pregnancy test as part of the screening process during to radiation exposure. The participant will be free to leave at any point during the examination.
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Total
n=46 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 15.22 • n=5 Participants
|
27 years
STANDARD_DEVIATION 3.86 • n=7 Participants
|
52 years
STANDARD_DEVIATION 18.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Single assessment time periodPopulation: Participants who completed the entire randomized reflex cough testing protocol were included in the analysis
Reflexive cough testing will use a capsaicin challenge that will assess individual's cough motor and cough sensory thresholds. A modified Borg scale ranging from 0 (no cough) to 10 (maximal urge to cough) will be used to quantify these thresholds. A cough sensory threshold will be defined as a concentration of capsaicin eliciting a perceived urge to cough of 1 (very slight) \>2/3 trials. A cough motor threshold will be the lowest concentration of capsaicin eliciting \>2 cough responses in 2/3 trials.
Outcome measures
| Measure |
Healthy Volunteers
n=34 Participants
This study will involve a single 90-minute visit. All women under the age of 62 will be asked to complete a pregnancy test as part of the screening process during to radiation exposure. Eligible participants will then undergo voluntary and reflexive cough testing, tongue pressure testing and a comprehensive instrumental swallowing evaluation. The entire duration of the exam will be under 90 minutes and the participant will be free to leave at any point during the examination.
Capsaicin: Participants will inspire deeply through the nebulizer coupled to the facemask and pneumotachograph. Each test inhalation will be separated by an interval of 2 minutes. This experimental trial consists of six (instead of 8) test solutions: 0, 25, 50, 100, 200 and 500 μM capsaicin in
|
|---|---|
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Reflexive Cough Testing (With Urge-to-Cough)
cough motor threshold
|
3 units on a scale
Interval 0.0 to 10.0
|
|
Reflexive Cough Testing (With Urge-to-Cough)
cough sensory threshold
|
5 units on a scale
Interval 0.5 to 10.0
|
PRIMARY outcome
Timeframe: Single VisitLVC temporal measures will be used to calculate the duration of laryngeal vestibule closure (dLVC)
Outcome measures
| Measure |
Healthy Volunteers
n=12 Participants
This study will involve a single 90-minute visit. All women under the age of 62 will be asked to complete a pregnancy test as part of the screening process during to radiation exposure. Eligible participants will then undergo voluntary and reflexive cough testing, tongue pressure testing and a comprehensive instrumental swallowing evaluation. The entire duration of the exam will be under 90 minutes and the participant will be free to leave at any point during the examination.
Capsaicin: Participants will inspire deeply through the nebulizer coupled to the facemask and pneumotachograph. Each test inhalation will be separated by an interval of 2 minutes. This experimental trial consists of six (instead of 8) test solutions: 0, 25, 50, 100, 200 and 500 μM capsaicin in
|
|---|---|
|
Duration of Laryngeal Vestibule Closure (dLVC)
5 swallows with head in chin up position
|
435 Milliseconds
Standard Deviation 41
|
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Duration of Laryngeal Vestibule Closure (dLVC)
5 swallows with e-stim to anterior neck
|
429 Milliseconds
Standard Deviation 61
|
|
Duration of Laryngeal Vestibule Closure (dLVC)
5 swallows with head in neutral position
|
461 Milliseconds
Standard Deviation 39
|
PRIMARY outcome
Timeframe: Single VisitLVC temporal measures will be used to calculate the laryngeal vestibule closure reaction time (LVCrt)
Outcome measures
| Measure |
Healthy Volunteers
n=12 Participants
This study will involve a single 90-minute visit. All women under the age of 62 will be asked to complete a pregnancy test as part of the screening process during to radiation exposure. Eligible participants will then undergo voluntary and reflexive cough testing, tongue pressure testing and a comprehensive instrumental swallowing evaluation. The entire duration of the exam will be under 90 minutes and the participant will be free to leave at any point during the examination.
Capsaicin: Participants will inspire deeply through the nebulizer coupled to the facemask and pneumotachograph. Each test inhalation will be separated by an interval of 2 minutes. This experimental trial consists of six (instead of 8) test solutions: 0, 25, 50, 100, 200 and 500 μM capsaicin in
|
|---|---|
|
Laryngeal Vestibule Closure Reaction Time (LVCrt)
5 swallows with head in chin up position
|
181 Milliseconds
Standard Deviation 31
|
|
Laryngeal Vestibule Closure Reaction Time (LVCrt)
5 swallows with e-stim to anterior neck
|
174 Milliseconds
Standard Deviation 23
|
|
Laryngeal Vestibule Closure Reaction Time (LVCrt)
5 swallows with head in neutral position
|
169 Milliseconds
Standard Deviation 34
|
SECONDARY outcome
Timeframe: BaselinePopulation: Participants who completed the voluntary cough testing protocol in its entirety were included in the analysis
Voluntary peak cough flow testing will be used to capture the volume of air expelled in the 1st second of cough as measured in PEF and FEV1.
Outcome measures
| Measure |
Healthy Volunteers
n=34 Participants
This study will involve a single 90-minute visit. All women under the age of 62 will be asked to complete a pregnancy test as part of the screening process during to radiation exposure. Eligible participants will then undergo voluntary and reflexive cough testing, tongue pressure testing and a comprehensive instrumental swallowing evaluation. The entire duration of the exam will be under 90 minutes and the participant will be free to leave at any point during the examination.
Capsaicin: Participants will inspire deeply through the nebulizer coupled to the facemask and pneumotachograph. Each test inhalation will be separated by an interval of 2 minutes. This experimental trial consists of six (instead of 8) test solutions: 0, 25, 50, 100, 200 and 500 μM capsaicin in
|
|---|---|
|
Voluntary Peak Cough Flow Testing (With Electronic Peak Cough Flow Meter Device)
|
3.15 liters per second
Standard Deviation 1.01
|
Adverse Events
Healthy Volunteers - Experiment #1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Healthy Volunteers - Experiment #2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Volunteers - Experiment #1
n=34 participants at risk
This study will involve a single 60-minute visit where healthy, eligible participants will undergo voluntary and reflexive cough testing.
Capsaicin: Participants will inspire deeply through the nebulizer coupled to the facemask and pneumotachograph. Each test inhalation will be separated by an interval of 2 minutes. This experimental trial consists of six (instead of 8) test solutions: 0, 25, 50, 100, 200 and 500 μM capsaicin
|
Healthy Volunteers - Experiment #2
n=12 participants at risk
This study will involve a single 60-minute visit where eligible participants will undergo an instrumental swallowing evaluation (videofluoroscopy). All women under the age of 62 will be asked to complete a pregnancy test as part of the screening process prior to radiation exposure. The entire duration of the exam will be under 60 minutes and the participant will be free to leave at any point during the examination.
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|---|---|---|
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Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.9%
1/34 • Number of events 1 • 12 months
Other (adverse event reporting): adverse events related to voluntary and reflex cough testing were collected during the single testing session. Participants were briefly monitored after testing and study was completed following their single visit.
|
0.00%
0/12 • 12 months
Other (adverse event reporting): adverse events related to voluntary and reflex cough testing were collected during the single testing session. Participants were briefly monitored after testing and study was completed following their single visit.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place