Normal Breathing and Swallowing in Healthy Volunteers

Phase 1

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers - Experiment 1	Videofluoroscopic swallow study	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	Videofluoroscopic swallow study	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.
Healthy Volunteers - Experiment 1	Capsaicin	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.

Primary Outcome Measures

Name	Time	Method
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)
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.

Secondary Outcome Measures

Name	Time	Method
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.