Cough Management app for refractory or unexplained chronic cough

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)

This trial will see if using a smartphone Cough Management program plus a smartwatch for four weeks lowers coughing and improves quality of life in adults 21–80 with refractory or unexplained chronic cough.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Hyfe Inc (other)
• Locations: 1 site (Wilmington, Delaware)
• Trial ID: NCT07070895 on ClinicalTrials.gov

What this trial studies

This single-cohort interventional study uses continuous cough monitoring with a Hyfe CoughMonitor smartwatch over six weeks (one-week baseline, four-week intervention, one-week follow-up) while participants complete in-app Cough Management lessons based on behavioral cough-suppression therapy. The primary objective is to compare each participant's objective cough rate (coughs per hour) during the four-week intervention to their one-week baseline. Secondary outcomes include cough bout/intensity metrics and patient-reported outcomes measured by the Leicester Cough Questionnaire and the PGI-S at baseline and after four weeks. Participants are asked to wear the watch continuously, charge it nightly, and avoid starting new cough treatments during the study period.

Who should consider this trial

Good fit: Adults aged 21 to 80 with a cough lasting at least eight weeks that is mostly nonproductive, a prior normal chest X-ray or CT ordered for the cough, at least one physician visit with inadequate relief, and willingness to wear the watch and complete the app lessons and questionnaires are ideal candidates.

Not a fit: People with a recent upper respiratory infection, a history of hemoptysis since the cough began, current smokers/vapers, or other exclusion criteria listed by the protocol are unlikely to benefit from this program.

Why it matters

Potential benefit: If successful, the program could reduce cough frequency and burden and offer a scalable non-drug option to improve quality of life for people with refractory or unexplained chronic cough.

How similar studies have performed: Behavioral cough-suppression therapies delivered by speech pathology have shown benefit in prior studies, but continuous smartwatch-monitored, smartphone-delivered Cough Management programs are relatively novel and less extensively tested.

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 consecutive pack-years smoking history within \<10 years prior to screening.
* Diagnosed with a chronic lung condition (COPD, emphysema, lung cancer, IPF, chronic bronchitis, asthma). Note: Suspected asthma without confirmed diagnosis or benefit from asthma therapy is not an exclusion.
* Current or past head/neck cancer.
* Difficulty swallowing.
* On ACE inhibitors, such as Benzapril (Lotensin), Captopril (Capoten), Enalapril/Enalaprilat (Vasotec oral and injectable), Fosinopril (Monopril), Lisinopril (Zestril and Prinivil), Moexipril (Univasc), Perindopril (Aceon), Quinapril (Accupril), Ramipril (Altace), and Trandolapril (Mavik)
* Prior treatment for cough by a speech-language pathologist.
* Living with another individual with a frequent cough that would interfere with monitoring.
* Participation in any cough intervention study within 30 days or 5 half-lives of the intervention.
* Major scheduled surgery during the study period.

Where this trial is running

Wilmington, Delaware

• Hyfe Inc. — Wilmington, Delaware, United States (RECRUITING)

Study contacts

• Study coordinator: Laurie Slovarp, PhD, CCC-SLP

Conditions: Refractory Chronic Cough, Unexplained Chronic Cough, Cough Hypersensitivity, chronic cough, hyfe, cough monitoring, coughpro, refractory chronic cough