Stimulation of the Larynx to Treat Unexplained Chronic Cough
Vibrotactile Stimulation of the Larynx to Treat Unexplained Chronic Cough
2 other identifiers
interventional
60
1 country
1
Brief Summary
Researchers will test the effect of non-invasive vibrotactile stimulation of the larynx on symptom severity of unexplained chronic cough.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 13, 2021
CompletedFirst Submitted
Initial submission to the registry
February 17, 2022
CompletedFirst Posted
Study publicly available on registry
March 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2027
August 11, 2025
August 1, 2025
6 years
February 17, 2022
August 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Assess usability of VTS device
% of participants indicating agree or strongly agree with statements of usability
3-7 weeks
Impact of VTS on cough symptoms
Pre-post comparison of LCQ scores
3-7 weeks
Study Arms (1)
Vibrotactile Stimulation
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 Neuromuscular impairment that may affect cough/laryngeal sensation and/or function (e.g., multiple system atrophy, Parkinson, CVA, vocal fold paralysis or paresis)
- Untreated carotid disease
- BMI \> 40 (for transmission of VTS through soft tissue)
- Current or recent (quit \< 3 months ago) smoking
- Known currently infectious cause for cough (e.g., TB, pertussis, COVID)
- History of known or suspected aspiration pneumonia
- Diagnosis or clinical suspicion of chronic obstructive pulmonary disease (COPD)
- Diagnosis or clinical suspicion of interstitial lung disease (ILD)
- Unmanaged reflux
- Unmanaged allergies/postnasal drip
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie Misono
University of Minnesota
Central Study Contacts
Clinical Research Coordinators Ashley Ramaker, MS or colleagues
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2022
First Posted
March 10, 2022
Study Start
July 13, 2021
Primary Completion (Estimated)
July 30, 2027
Study Completion (Estimated)
December 30, 2027
Last Updated
August 11, 2025
Record last verified: 2025-08