Normal Breathing and Swallowing in Healthy Volunteers

Establishing Normal Swallowing and Breathing Profiles in Healthy Adults Across the Age Span

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Capsaicin; Device: Videofluoroscopic swallow study

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Volunteers - Experiment 1; 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.	Drug: 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 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).; Other Names: Reflexive Cough; Device: Videofluoroscopic swallow study; 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.
Experimental: Healthy Volunteers - Experiment 2; 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.	Device: Videofluoroscopic swallow study; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Emily Plowman, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2017
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: April 17, 2017
• First Submitted That Met QC Criteria: April 19, 2017
• First Posted (Actual): April 20, 2017

Study Record Updates

• Last Update Posted (Actual): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: healthy; volunteer
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Dermatologic Agents; Antipruritics; Capsaicin
• Other Study ID Numbers: IRB201700132 - A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study team will not be sharing individual IDP information with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No