Recruiting NCT05273190
Stimulation of the Larynx to Treat Unexplained Chronic Cough
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vibrotactile Stimulation.
- Who it may be relevant to
- Registry conditions: Cough. Basic parameters: 18 years — 88 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Vibrotactile Stimulation of the Larynx to Treat Unexplained Chronic Cough
Overview
Researchers will test the effect of non-invasive vibrotactile stimulation of the larynx on symptom severity of unexplained chronic cough.
Interventions
- 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.
Primary outcome measures
- Assess usability of VTS device [Time frame: 3-7 weeks]
- Impact of VTS on cough symptoms [Time frame: 3-7 weeks]
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)
- Diagnosis or clinical suspicion of interstitial lung disease (ILD)
- Unmanaged reflux
- Unmanaged allergies/postnasal drip
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Minnesota — Minneapolis
Identifiers
NCT: NCT05273190 · ENT-2020-28903 · R34HL174877