Cough Management Wellness App for Refractory or Unexplained Chronic Cough

Part of paid clinical trials in Wilmington, Delaware.

Sponsor
Hyfe Inc
Study ID
NCT07070895
Status
Recruiting

Conditions

  • Cough Hypersensitivity
  • Refractory Chronic Cough
  • Unexplained Chronic Cough

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cough Management — BEHAVIORAL
    CoughPro is a smartphone wellness application that uses algorithms to detect and count coughs continuously and passively (similar to a "step counter," but for cough). CoughPro also includes a Cough Management (CM) component, which delivers short, structured behavioral lessons (based on BCST) designed to help users recognize their urge to cough and apply cough suppression strategies in real-world settings. The Cough Management wellness feature is the key area of investigation in this study. The novel CM program is delivered entirely through participants' devices. The application aims to help users better understand and manage their cough by coupling real-time cough detection with self-management BCST resources: * Reduce cough frequency (coughs per hour). * Reduce cough intensity (as measured by cough bouts). * Improve cough-related quality of life (as reported by patients and its correlation with cough-free time as measured objectively).
  • CoughMonitor Suite — DEVICE
    CoughMonitor Suite's smartwatch is used in this study to continuously, automatically, and passively monitor cough frequency in a fully privacy-preserving way - no audio is recorded, stored, or synced to the cloud, and no human is in the loop.

Study Details

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.

Key Dates

Start date
Mar 27, 2025
Status verified
Sep 2025
Primary completion
Aug 8, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cough Management
    CoughPro wellness application includes a Cough Management (CM) component, which delivers short, structured behavioral lessons (based on BCST) designed to help users recognize their urge to cough and apply cough suppression strategies in real-world settings. The Cough Management wellness feature is the key area of investigation in this study.

Primary Outcome Measure

Change in objective cough rate (coughs/hour) [ Time Frame: From baseline (week minus 1) to end of Week 4 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hyfe Inc.WilmingtonDelaware19801
Laurie Slovarp, PhD, CCC-SLP
302-618-2348

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