NCT07070895 Cough Management Wellness App for Refractory or Unexplained Chronic Cough
| NCT ID | NCT07070895 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hyfe Inc |
| Condition | Refractory Chronic Cough |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-03-27 |
| Primary Completion | 2025-08-08 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Age 21 or older. * Currently suffering from a cough that started at least 8 weeks ago that is largely unproductive (i.e., at least 50% of the time the cough produces zero mucus that needs to be spit out or swallowed). * Normal chest X-ray or chest CT scan at some point that was prescribed specifically for their cough. * At least one physician visit for cough with standard-of-care therapy but inadequate symptom relief. * Stability of treatment: willing to avoid new cough treatments during study or report changes if they occur. * Ability to comply: willing/able to wear the watch daily for the required duration of study and to complete all required questionnaires. * Informed consent: understanding of the study procedures and agreement to comply with protocol. Exclusion Criteria: * Recent upper respiratory infection (past 4 weeks). * History of hemoptysis (coughing up blood) since onset of the current cough. * Current smoker (incl. vaping) of any substance. * ≥10 cons