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Stimulation of the Larynx to Treat Unexplained Chronic Cough

Primary Purpose

Cough

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vibrotactile Stimulation
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cough focused on measuring Chronic cough

Eligibility Criteria

18 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vibrotactile Stimulation

Arm Description

Outcomes

Primary Outcome Measures

Assess usability of VTS device
% of participants indicating agree or strongly agree with statements of usability
Impact of VTS on cough symptoms
Pre-post comparison of LCQ scores

Secondary Outcome Measures

Full Information

First Posted
February 17, 2022
Last Updated
September 6, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05273190
Brief Title
Stimulation of the Larynx to Treat Unexplained Chronic Cough
Official Title
Vibrotactile Stimulation of the Larynx to Treat Unexplained Chronic Cough
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2021 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough
Keywords
Chronic cough

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vibrotactile Stimulation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Vibrotactile Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assess usability of VTS device
Description
% of participants indicating agree or strongly agree with statements of usability
Time Frame
3 weeks
Title
Impact of VTS on cough symptoms
Description
Pre-post comparison of LCQ scores
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Research Coordinators (Anna Sombrio, MPH, or colleagues)
Phone
612-301-5569
Email
coughstudy@umn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Stockness
Email
nicho656@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Misono
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Misono
Phone
612-626-5526
Email
smisono@umn.edu

12. IPD Sharing Statement

Learn more about this trial

Stimulation of the Larynx to Treat Unexplained Chronic Cough

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