Cough Management app for refractory or unexplained chronic cough

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hyfe Inc.
  Wilmington, Delaware, United States Recruiting

Study contacts

• Study coordinator: Laurie Slovarp, PhD, CCC-SLP
• Email: study@hyfe.com
• Phone: 302-618-2348

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Testing Duloxetine and Amitriptyline for Chronic Cough Relief

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.