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NCT05273190 Clinical Trial

Stimulation of the Larynx to Treat Unexplained Chronic Cough

Cough Clinical Trial

Official title:
Vibrotactile Stimulation of the Larynx to Treat Unexplained Chronic Cough

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05273190
Other study ID # ENT-2020-28903
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 13, 2021
Est. completion date October 1, 2024

Study information
Verified date September 2023
Source University of Minnesota
Contact Clinical Research Coordinators (Anna Sombrio, MPH, or colleagues
Phone 612-301-5569
Email coughstudy@umn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date October 1, 2024
Est. primary completion date October 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 88 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

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