Phase 2
N=49
Normal Breathing and Swallowing in Healthy Volunteers
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT03122145 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Reflexive Cough Testing (With Urge-to-Cough) — 3; 5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Capsaicin (Drug); Videofluoroscopic swallow study (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reflexive Cough Testing (With Urge-to-Cough) |
3; 5 | — |
| PRIMARY Duration of Laryngeal Vestibule Closure (dLVC) |
435; 429; 461 | — |
| PRIMARY Laryngeal Vestibule Closure Reaction Time (LVCrt) |
181; 174; 169 | — |
| SECONDARY Voluntary Peak Cough Flow Testing (With Electronic Peak Cough Flow Meter Device) |
3.15 | 0.0005 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03122145). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.