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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

Tracking Information
First Submitted Date  ICMJE February 17, 2022
First Posted Date  ICMJE March 10, 2022
Last Update Posted Date March 27, 2023
Actual Study Start Date  ICMJE July 13, 2021
Estimated Primary Completion Date July 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2022)
  • Assess usability of VTS device [ Time Frame: 3 weeks ]
    % of participants indicating agree or strongly agree with statements of usability
  • Impact of VTS on cough symptoms [ Time Frame: 3 weeks ]
    Pre-post comparison of LCQ scores
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stimulation of the Larynx to Treat Unexplained Chronic Cough
Official Title  ICMJE Vibrotactile Stimulation of the Larynx to Treat Unexplained Chronic Cough
Brief Summary Researchers will test the effect of non-invasive vibrotactile stimulation of the larynx on symptom severity of unexplained chronic cough.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cough
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Vibrotactile Stimulation
Intervention: Device: Vibrotactile Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 9, 2022)		 60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2023
Estimated Primary Completion Date July 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 88 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Research Coordinators (Anna Sombrio, MPH, or colleagues) 612-301-5569 coughstudy@umn.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05273190
Other Study ID Numbers  ICMJE ENT-2020-28903
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Minnesota
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Minnesota
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephanie Misono University of Minnesota
PRS Account University of Minnesota
Verification Date March 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP