Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
NCT07070895

Cough Management Wellness App for Refractory or Unexplained Chronic Cough

Led by Hyfe Inc · Updated on 2025-09-11

20

Participants Needed

1

Research Sites

22 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this single-cohort clinical trial is to learn whether a smartphone-based Cough Management (CM) program can reduce cough frequency and burden in adults (21-80 years) who have refractory or unexplained chronic cough.  The main questions it aims to answer are: * Does four weeks of using the CM feature in the CoughPro app lower objective cough rate (coughs per hour) compared with each participant's one-week baseline?  * Does the program also lessen cough intensity (bout metrics) and improve patient-reported quality-of-life scores on the Leicester Cough Questionnaire and PGI-S? Participants will: * Wear a Hyfe CoughMonitor smartwatch continuously for 6 weeks (1-week baseline, 4-week intervention, 1-week follow-up), charging it nightly.  * Complete science-based in-app CM lessons based on behavioral cough-suppression therapy and practice the techniques during the 4-week intervention. * Fill out online questionnaires (LCQ and PGI-S) at baseline and at the end of Week 4. * Join a brief exit interview, then return the smartwatch and receive a compensation voucher.

CONDITIONS

Official Title

Cough Management Wellness App for Refractory or Unexplained Chronic Cough

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 21 or older.
  • Currently have a cough lasting at least 8 weeks that is mostly unproductive (at least 50% of the time produces no mucus).
  • Have had a normal chest X-ray or chest CT scan specifically for your cough.
  • Have visited a physician for your cough and received standard treatment with inadequate symptom relief.
  • Willing to avoid new cough treatments during the study or report any changes.
  • Able and willing to wear the cough monitoring watch daily and complete all required questionnaires.
  • Understand the study procedures and agree to follow the study protocol.
Not Eligible

You will not qualify if you...

  • Had an upper respiratory infection within the past 4 weeks.
  • History of coughing up blood since the current cough began.
  • Current smoker or vaping any substance.
  • Have 10 or more consecutive pack-years smoking history within 10 years prior to screening.
  • Diagnosed with chronic lung conditions such as COPD, emphysema, lung cancer, IPF, chronic bronchitis, or asthma (unless asthma is suspected but not confirmed or treated).
  • Current or past head or neck cancer.
  • Difficulty swallowing.
  • Taking ACE inhibitor medications like Benzapril, Captopril, Enalapril, Fosinopril, Lisinopril, Moexipril, Perindopril, Quinapril, Ramipril, or Trandolapril.
  • Prior cough treatment by a speech-language pathologist.
  • Living with someone who coughs frequently which could interfere with monitoring.
  • Participated in another cough intervention study within 30 days or 5 half-lives of that intervention.
  • Scheduled for major surgery during the study period.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hyfe Inc.

Wilmington, Delaware, United States, 19801

Actively Recruiting

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Research Team

L

Laurie Slovarp, PhD, CCC-SLP

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Cough Management Wellness App for Refractory or Unexplained Chronic Cough | DecenTrialz