Normal Breathing and Swallowing in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): Capsaicin; Videofluoroscopic swallow study
Intervention type(s): Drug; Device
Intervention description(s): 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.
Other intervention name(s): Reflexive Cough
Intervention MeSH terms: Capsaicin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy; volunteer