Stimulation of the Larynx to Treat Unexplained Chronic Cough

University of Minnesota (UMN)

Status: Enrolling

Conditions: Cough

Treatments: Device: Vibrotactile Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05273190

ENT-2020-28903

R34HL174877 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 88 years old

Volunteers: No 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 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Vibrotactile Stimulation

Experimental group

Treatment:

Device: Vibrotactile Stimulation