Stimulation of the Larynx to Treat Unexplained Chronic Cough | NCT05273190

Studies
Stimulation of the Larynx to Treat Unexplained Chronic Cough

NCT05273190

Sponsor

University of Minnesota

Status

Recruiting

Last Update Posted

Jun 15, 2026Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Cough

Interventions

Vibrotactile Stimulation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R34HL174877	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 13, 2021Actual

Primary Completion Date

Jun 1, 2027Estimated

Completion Date

Jun 30, 2027Estimated

First Submitted Date

Feb 17, 2022

First Submission Date that Met QC Criteria

Mar 9, 2022

First Posted Date

Mar 10, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2026

Last Update Posted Date

Jun 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vibrotactile Stimulation	Experimental		Device: Vibrotactile Stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vibrotactile Stimulation	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

88 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clinical Research Coordinators Ashley Ramaker, MS or colleagues	Contact	612-625-3278		coughstudy@umn.edu
Ali Stockness	Contact			nicho656@umn.edu

Overall Officials

Name	Affiliation	Role
Stephanie Misono	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota	Recruiting	Minneapolis	Minnesota	55455	United States

Condition Browse Module

MeSH Terms

ID	Term
D003371	Cough
D000096822	Chronic Cough

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided