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Completed

NCT Number: NCT03122145

Normal Breathing and Swallowing in Healthy Volunteers

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.

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Key information

Conditions

Healthy

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: Reflexive Cough

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.

Primary outcomes

  1. Reflexive Cough Testing (With Urge-to-Cough)

    Time frame: 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.

  2. Duration of Laryngeal Vestibule Closure (dLVC)

    Time frame: Single Visit

    LVC temporal measures will be used to calculate the duration of laryngeal vestibule closure (dLVC)

  3. Laryngeal Vestibule Closure Reaction Time (LVCrt)

    Time frame: Single Visit

    LVC temporal measures will be used to calculate the laryngeal vestibule closure reaction time (LVCrt)

Secondary outcomes

  1. Voluntary Peak Cough Flow Testing (With Electronic Peak Cough Flow Meter Device)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 20, 2017
Registry last updated
Jan 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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