Stimulation of the Larynx to Treat Unexplained Chronic Cough

September 6, 2023 updated by: University of Minnesota

Vibrotactile Stimulation of the Larynx to Treat Unexplained Chronic Cough

Researchers will test the effect of non-invasive vibrotactile stimulation of the larynx on symptom severity of unexplained chronic cough.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Clinical Research Coordinators (Anna Sombrio, MPH, or colleagues)
  • Phone Number: 612-301-5569
  • Email: coughstudy@umn.edu

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18-88
  • >8 weeks of cough
  • Cough visual analogue scale (VAS): Rating of 30 or greater on a 0-100 cough severity scale
  • Ability to provide informed consent and independently complete questionnaires
  • Ability to read and speak English

Exclusion Criteria:

  • Electronic implants (e.g., pacemaker)
  • Currently doing speech therapy for cough
  • Contraindications to safe or effective VTS device use
  • No regular access to wifi internet

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vibrotactile Stimulation
Device: Vibrotactile Stimulation
Small electric motors, similar to a vibrating cell phone or gaming joystick, deliver vibration to the throat. Participants will assess cough symptoms throughout the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess usability of VTS device
Time Frame: 3 weeks
% of participants indicating agree or strongly agree with statements of usability
3 weeks
Impact of VTS on cough symptoms
Time Frame: 3 weeks
Pre-post comparison of LCQ scores
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Stephanie Misono, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2021

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

February 17, 2022

First Submitted That Met QC Criteria

March 9, 2022

First Posted (Actual)

March 10, 2022

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENT-2020-28903

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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