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Stimulation of the Larynx to Treat Unexplained Chronic Cough

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05273190
Recruitment Status : Recruiting
First Posted : March 10, 2022
Last Update Posted : March 27, 2023
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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Brief Summary:
Researchers will test the effect of non-invasive vibrotactile stimulation of the larynx on symptom severity of unexplained chronic cough.

Condition or disease Intervention/treatment Phase
Cough Device: Vibrotactile Stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vibrotactile Stimulation of the Larynx to Treat Unexplained Chronic Cough
Actual Study Start Date : July 13, 2021
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vibrotactile Stimulation 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.


Outcome Measures
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Primary Outcome Measures :
  1. Assess usability of VTS device [ Time Frame: 3 weeks ]
    % of participants indicating agree or strongly agree with statements of usability

  2. Impact of VTS on cough symptoms [ Time Frame: 3 weeks ]
    Pre-post comparison of LCQ scores


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 88 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05273190


Contacts
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Contact: Clinical Research Coordinators (Anna Sombrio, MPH, or colleagues) 612-301-5569 coughstudy@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Stephanie Misono    612-626-5526    smisono@umn.edu   
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Stephanie Misono University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT05273190    
Other Study ID Numbers: ENT-2020-28903
First Posted: March 10, 2022    Key Record Dates
Last Update Posted: March 27, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of Minnesota:
Chronic cough
Additional relevant MeSH terms:
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Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory