Stimulation of the Larynx to Treat Unexplained Chronic Cough

NCT ID: NCT05273190

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-13

Study Completion Date

2027-12-30

Brief Summary

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

Detailed Description

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Conditions

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Cough

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vibrotactile Stimulation

Group Type EXPERIMENTAL

Vibrotactile Stimulation

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

88 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephanie Misono

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Clinical Research Coordinators Ashley Ramaker, MS or colleagues

Role: CONTACT

612-625-3278

Ali Stockness

Role: CONTACT

Facility Contacts

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Stephanie Misono

Role: primary

612-626-5526

Other Identifiers

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R34HL174877

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ENT-2020-28903

Identifier Type: -

Identifier Source: org_study_id

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