Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers - Experiment 1 | Experimental | This study will involve a single 60-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. 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. |
|
| Healthy Volunteers - Experiment 2 | Experimental | This study will involve a single 60-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 a instrumental swallowing evaluation (videofluoroscopy). 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capsaicin | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Single assessment time period |
| Duration of Laryngeal Vestibule Closure (dLVC) | LVC temporal measures will be used to calculate the duration of laryngeal vestibule closure (dLVC) | Single Visit |
| Laryngeal Vestibule Closure Reaction Time (LVCrt) | LVC temporal measures will be used to calculate the laryngeal vestibule closure reaction time (LVCrt) | Single Visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Emily Plowman, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States |
The study team will not be sharing individual IDP information with other researchers.
Not provided
Not provided
Not provided
Not provided
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).
2018-2019 HealthStreet university approved flyers
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants were healthy controls recruited from the Gainesville community and university population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants who completed the entire randomized reflex cough testing protocol were included in the analysis | Posted | Median | Full Range | units on a scale | Single assessment time period |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Volunteers - Experiment #1 | 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Reported shortness of breath following the maximum capsaicin dose during reflex cough testing. Participant was provided water and took a 5-minute break. They completed the study without issue and were sent home after a brief monitoring period |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lauren Tabor Gray | Holy Cross Hospital | 954 542 3429 | lauren.tabor@holy-cross.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Jan 31, 2019 | Jan 9, 2020 | Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 1, 2019 | Jan 9, 2020 | SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002211 | Capsaicin |
| ID | Term |
|---|---|
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000475 | Alkenes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Videofluoroscopic swallow study | Device | 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. |
|
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Duration of Laryngeal Vestibule Closure (dLVC) | LVC temporal measures will be used to calculate the duration of laryngeal vestibule closure (dLVC) | Posted | Mean | Standard Deviation | Milliseconds | Single Visit |
|
|
|
| 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. | Participants who completed the voluntary cough testing protocol in its entirety were included in the analysis | Posted | Mean | Standard Deviation | liters per second | Baseline |
|
|
|
|
| Primary | Laryngeal Vestibule Closure Reaction Time (LVCrt) | LVC temporal measures will be used to calculate the laryngeal vestibule closure reaction time (LVCrt) | Posted | Mean | Standard Deviation | Milliseconds | Single Visit |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 1 |
| 34 |
| EG001 | Healthy Volunteers - Experiment #2 | 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. | 0 | 12 | 0 | 12 | 0 | 12 |
|
Not provided
Not provided
| D006839 |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
|
|