Normal Breathing and Swallowing in Healthy Volunteers

NCT03122145 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: IRB201700132 - A
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

healthy; volunteer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Voluntary Peak Cough Flow Testing (With Electronic Peak Cough Flow Meter Device)

  Baseline

Study Arms (2)

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.

Drug: Capsaicin; Device: Videofluoroscopic swallow study

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.

Device: Videofluoroscopic swallow study

Interventions

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).

Also known as: Reflexive Cough

Healthy Volunteers - Experiment 1

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 1; Healthy Volunteers - Experiment 2

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Interventions

Capsaicin

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Results Point of Contact

• Title: Lauren Tabor Gray
• Organization: Holy Cross Hospital

lauren.tabor@holy-cross.com

954 542 3429

Study Officials

• Emily Plowman, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 20, 2017
• Study Start: May 23, 2017
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: January 14, 2021
• Results First Posted: March 27, 2020

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)