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NCT03122145 · ClinicalTrials.gov registry record · Phase 1

Normal Breathing and Swallowing in Healthy Volunteers

A Phase 1 study, sponsored by University of Florida.

Completed
Registry status
Phase 1
Development phase
49
Enrollment target

NCT03122145: Completed Phase 1 study, sponsored by University of Florida.

NCT03122145 is a Phase 1 study that has completed, run by University of Florida. The registered enrollment target is 49 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03122145, a Phase 1 study, has completed, sponsored by University of Florida.

COMPLETED
Registry status
Phase 1
Development phase
49 participants
Enrollment target

Study 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.

Primary Outcome

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 tr

Interventions

  • DRUG Capsaicin
  • DEVICE Videofluoroscopic swallow study

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2017-05-23
Est. Completion 2019-02-28
Phase Phase 1
University of Florida

1,106 total trials

What the finished NCT03122145 record still lists

NCT03122145 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower).

The record links to 0 conditions, and to 2 interventions - of which Capsaicin is the first listed.

NCT03122145 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03122145 about?

NCT03122145 is a clinical study titled "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.

What is the current status of trial NCT03122145?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2017-05-23. Estimated completion is 2019-02-28.

What interventions are being tested in trial NCT03122145?

The interventions under investigation include: Capsaicin (DRUG), Videofluoroscopic swallow study (DEVICE).

Who is sponsoring clinical trial NCT03122145?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03122145's enrollment target sits among peer trials

49 1017th of 2000 higher than 976 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03122145, the US trial registry maintained by the National Library of Medicine. NCT03122145 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.