Healthy
Conditions
Keywords
healthy, volunteer
Brief summary
The purpose of this study is to establish normative values for clinical testing measures of swallow, respiratory and cough functions. This will aide in establishing degree of impairment in disordered populations, and in identifying efficacious treatment paradigms for dysphagia.
Detailed description
The prevalence of dysphagia may be as high as 22% in individuals over 50 years of age. There are few therapeutic options and minimal management strategies offered to treat these individuals and improve sequelae of dysphagia. Dysphagia contributes to malnutrition, aspiration, pneumonia, reduced quality of life and increased mortality in neurodegenerative disease such as ALS. One reason for this is the lack of normative data across various measures of swallowing and respiratory function. As a result, detecting early impairments in swallowing physiology is difficult, given the variability of swallowing and unknown normative value range of swallowing physiology. Therefore, the goal of this study is to complete clinical tests of swallowing and cough function in healthy volunteers to establish normative data. This will contribute to future study in disordered populations, to determine degree and severity of impairment and efficacious treatment and management strategies based on impairment. The purpose of this study is to establish normative values for clinical testing measures of swallow, respiratory and cough functions. This will aide in establishing degree of impairment in disordered populations, and in identifying efficacious treatment paradigms for dysphagia.
Interventions
DRUGCapsaicin
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 80% physiological saline, 20% ethanol. Participants will inhale single vital capacity breaths of capsaicin solution via an air-powered dosimeter (KoKoDigidoser; Pulmonary Data Services Instrumentation Inc; Louisville, CO). The reflex cough test ends when the participant coughs at least 2 times in response to one inhalation dose, or receives a dose of the highest concentration (500 μM).
The swallowing systems core laboratory is fully equipped to perform videofluoroscopy with a c-arm (OEC 9900) that is dedicated solely to research purposes. Videofluoroscopy recordings will be kept to a minimum and turned on only during completion of a specific testing task. Video recording and images captured during the videofluoroscopy will be synced and saved for data analysis. Videofluoroscopy allows for time-synced, frame-by-frame data analysis for the specific measures taken during swallowing tasks. The physiological swallowing measures (temporal and kinematic of the base of tongue, oropharynx, and hyolarynx complex during swallowing) to be analyzed cannot be visualized with any other technique. All swallowing tasks will be completed using barium in order to visualize the bolus during movement of various swallowing muscles and structures.
Sponsors
University of Florida
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Up to 120 individuals will be included in this study. * Subjects will include both male and females who are aged between 18-100 * Healthy and with no major medical conditions. * No specific gender or race will be excluded or targeted for participation in this study.
Exclusion criteria
* Adults who are pregnant * Those with major medical conditions (i.e., swallowing impairment, brain injury) will be excluded from this study. * Anyone with allergy to barium will be excluded from this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reflexive Cough Testing (With Urge-to-Cough) | Single assessment time period | 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. |
| Duration of Laryngeal Vestibule Closure (dLVC) | Single Visit | LVC temporal measures will be used to calculate the duration of laryngeal vestibule closure (dLVC) |
| Laryngeal Vestibule Closure Reaction Time (LVCrt) | Single Visit | LVC temporal measures will be used to calculate the laryngeal vestibule closure reaction time (LVCrt) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Voluntary Peak Cough Flow Testing (With Electronic Peak Cough Flow Meter Device) | Baseline | 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. |
Countries
United States
Participant flow
Recruitment details
2018-2019 HealthStreet university approved flyers
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Healthy Volunteers - Experiment #1 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. | 34 |
| Healthy Volunteers - Experiment #2 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. | 12 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Concurrent respiratory disease | 3 | 0 |
Baseline characteristics
| Characteristic | Healthy Volunteers - Experiment #2 | Total | Healthy Volunteers - Experiment #1 |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 16 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 30 Participants | 18 Participants |
| Age, Continuous | 27 years STANDARD_DEVIATION 3.86 | 52 years STANDARD_DEVIATION 18.44 | 60.9 years STANDARD_DEVIATION 15.22 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 14 Participants | 2 Participants |
| Race (NIH/OMB) White | 0 Participants | 25 Participants | 25 Participants |
| Region of Enrollment United States | 12 Participants | 46 Participants | 34 Participants |
| Sex: Female, Male Female | 10 Participants | 30 Participants | 20 Participants |
| Sex: Female, Male Male | 2 Participants | 16 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 12 |
| other Total, other adverse events | 1 / 34 | 0 / 12 |
| serious Total, serious adverse events | 0 / 34 | 0 / 12 |
Outcome results
Primary
Duration of Laryngeal Vestibule Closure (dLVC)
LVC temporal measures will be used to calculate the duration of laryngeal vestibule closure (dLVC)
Time frame: Single Visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Volunteers | Duration of Laryngeal Vestibule Closure (dLVC) | 5 swallows with head in chin up position | 435 Milliseconds | Standard Deviation 41 |
| Healthy Volunteers | Duration of Laryngeal Vestibule Closure (dLVC) | 5 swallows with e-stim to anterior neck | 429 Milliseconds | Standard Deviation 61 |
| Healthy Volunteers | Duration of Laryngeal Vestibule Closure (dLVC) | 5 swallows with head in neutral position | 461 Milliseconds | Standard Deviation 39 |
Primary
Laryngeal Vestibule Closure Reaction Time (LVCrt)
LVC temporal measures will be used to calculate the laryngeal vestibule closure reaction time (LVCrt)
Time frame: Single Visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Volunteers | Laryngeal Vestibule Closure Reaction Time (LVCrt) | 5 swallows with head in chin up position | 181 Milliseconds | Standard Deviation 31 |
| Healthy Volunteers | Laryngeal Vestibule Closure Reaction Time (LVCrt) | 5 swallows with e-stim to anterior neck | 174 Milliseconds | Standard Deviation 23 |
| Healthy Volunteers | Laryngeal Vestibule Closure Reaction Time (LVCrt) | 5 swallows with head in neutral position | 169 Milliseconds | Standard Deviation 34 |
Primary
Reflexive Cough Testing (With Urge-to-Cough)
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.
Time frame: Single assessment time period
Population: Participants who completed the entire randomized reflex cough testing protocol were included in the analysis
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Healthy Volunteers | Reflexive Cough Testing (With Urge-to-Cough) | cough motor threshold | 3 units on a scale |
| Healthy Volunteers | Reflexive Cough Testing (With Urge-to-Cough) | cough sensory threshold | 5 units on a scale |
Secondary
Voluntary Peak Cough Flow Testing (With Electronic Peak Cough Flow Meter Device)
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.
Time frame: Baseline
Population: Participants who completed the voluntary cough testing protocol in its entirety were included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Volunteers | Voluntary Peak Cough Flow Testing (With Electronic Peak Cough Flow Meter Device) | 3.15 liters per second | Standard Deviation 1.01 |
Comparison: Hypothesis that voluntary cough \> reflex cough strength and effectiveness in healthy volunteersp-value: 0.0005ANOVA