CoughNCT05273190
Stimulation of the Larynx to Treat Unexplained Chronic Cough
A study testing Vibrotactile Stimulation in people with Cough, run by University of Minnesota at 1 site in United States.
Trial summary
Researchers will test the effect of non-invasive vibrotactile stimulation of the larynx on symptom severity of unexplained chronic cough. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Cough
- What is being tested?
- Vibrotactile Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2021to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Clinical Research Coordinators Ashley Ramaker, MS or colleagues contact
Ali Stockness contact
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Stephanie Misono, 612-626-5526, smisono@umn.edu
About this study
Official title: Vibrotactile Stimulation of the Larynx to Treat Unexplained Chronic Cough
Researchers will test the effect of non-invasive vibrotactile stimulation of the larynx on symptom severity of unexplained chronic cough.
- Conditions
- Cough
- Being tested
- Vibrotactile Stimulation
- Keywords
- Chronic cough
- Medical subject headings
- Cough, Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrotactile StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Vibrotactile Stimulation | Experimental | Not described Receives: Device: Vibrotactile Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess usability of VTS device
% of participants indicating agree or strongly agree with statements of usability
Measured: 3-7 weeks
Impact of VTS on cough symptoms
Pre-post comparison of LCQ scores
Measured: 3-7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start13 Jul 2021
- Primary completion1 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Misono, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273190
- Sponsor's protocol ID
- ENT-2020-28903
- Other IDs
- R34HL174877
- Status last verified
- Jun 2026
- First submitted
- 17 Feb 2022
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibrotactile Stimulation of the Larynx to Treat Unexplained Chronic Cough
- ClinicalTrials.gov ID
- NCT05273190
- Acronym / sponsor ID
- ENT-2020-28903
- Conditions
- Cough
- Keywords
- Chronic cough
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers will test the effect of non-invasive vibrotactile stimulation of the larynx on symptom severity of unexplained chronic cough.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vibrotactile Stimulation | Experimental | Device: Vibrotactile Stimulation |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrotactile StimulationSmall 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. | Device | Vibrotactile Stimulation |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Research Coordinators Ashley Ramaker, MS or colleagues contact
Ali Stockness contact
Stephanie Misono principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrotactile Stimulation in people with Cough, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Coordinators Ashley Ramaker, MS or colleagues (612-625-3278, coughstudy@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess usability of VTS device (time frame: 3-7 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.