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Clinical Trials/NCT05273190
NCT05273190
Recruiting
N/A

Vibrotactile Stimulation of the Larynx to Treat Unexplained Chronic Cough

University of Minnesota1 site in 1 country60 target enrollmentJuly 13, 2021
ConditionsCough

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cough
Sponsor
University of Minnesota
Enrollment
60
Locations
1
Primary Endpoint
Assess usability of VTS device
Status
Recruiting
Last Updated
8 months ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
July 13, 2021
End Date
December 30, 2027
Last Updated
8 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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 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)

Outcomes

Primary Outcomes

Assess usability of VTS device

Time Frame: 3-7 weeks

% of participants indicating agree or strongly agree with statements of usability

Impact of VTS on cough symptoms

Time Frame: 3-7 weeks

Pre-post comparison of LCQ scores

Study Sites (1)

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