A Prospective Decentralized Investigation of the Effect of a Cough Management Feature Inside a Wellness Application (CoughPro) in Refractory or Unexplained Chronic Cough (RCC/UCC)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• 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.

Locations
United States
Delaware
Hyfe Inc.
RECRUITING
Wilmington
Contact Information
Primary
Laurie Slovarp, PhD, CCC-SLP
study@hyfe.com
302-618-2348
Time Frame
Start Date: 2025-03-27
Estimated Completion Date: 2025-09
Participants
Target number of participants: 20
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Hyfe Inc

This content was sourced from clinicaltrials.gov