Laryngeal Pacing Device for Bilateral Vocal Fold Paralysis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Vanderbilt University Medical Center, Nashville, TNBilateral Vocal Fold ParalysisLaryngeal Pacing Device - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new laryngeal pacemaker device to see if it is safe and can help people with bilateral vocal fold paralysis.

Eligible Conditions
  • Bilateral Vocal Fold Paralysis

Treatment Effectiveness

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: 12 months

12 months
Better quality of life (QOL) outcomes due to laryngeal pacing device, self assessed via patient reported outcome surveys.
Better voice quality as assessed by decrease in standard assessment testing (Consensus Auditory Perceptual Evaluation of Voice or CAPE-V).
Improved ventilation due to laryngeal pacing device as assessed by increase in standard assessment testing (peak inspiratory flow or PIF).
Increase in exercise tolerance due to laryngeal pacing device as assessed by treadmill testing.
Increased glottal area due to laryngeal pacing device as assessed by increase in normalized glottal area (NGA) results.

Trial Safety

Trial Design

2 Treatment Groups

Early Activation of Laryngeal Pacing device
1 of 2
Delayed Activation of Laryngeal Pacing device
1 of 2

Experimental Treatment

Non-Treatment Group

12 Total Participants · 2 Treatment Groups

Primary Treatment: Laryngeal Pacing Device · Has Placebo Group · N/A

Early Activation of Laryngeal Pacing device
Device
Experimental Group · 1 Intervention: Laryngeal Pacing Device · Intervention Types: Device
Delayed Activation of Laryngeal Pacing device
Device
ShamComparator Group · 1 Intervention: Laryngeal Pacing Device · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
784 Previous Clinical Trials
599,225 Total Patients Enrolled
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
293 Previous Clinical Trials
176,303 Total Patients Enrolled
David L. Zealear, PhDPrincipal InvestigatorVanderbilt University Medical Center
1 Previous Clinical Trials
2 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You may or may not have a tracheostomy.

Who else is applying?

What state do they live in?
Florida100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Vanderbilt University Medical Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

How many volunteers are partaking in this medical experiment?

"Affirmative. According to clinicaltrials.gov, this research study is still open for enrolment; the protocol was initially released on January 14th 2021 and received its most recent update in October 6th 2022. To complete the trial 12 participants must be enrolled from a single site." - Anonymous Online Contributor

Unverified Answer

Is enrollment ongoing for this clinical trial?

"Data from clinicaltrials.gov indicates that this experiment is actively seeking participants, with the original posting occurring on January 14th 2021 and the most recent edits being made October 6th 2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.