Cough Management Wellness App for Refractory or Unexplained Chronic Cough

Not Applicable

Recruiting

• Conditions: Refractory Chronic Cough; Unexplained Chronic Cough; Cough Hypersensitivity

• Registration Number: NCT07070895
• Lead Sponsor: Hyfe Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-27
• Study First Submitted: 2025-06-20
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-17
• Last Update Posted: 2025-07-17
• Primary Completion: 2025-08
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in objective cough rate (coughs/hour)	From baseline (week minus 1) to end of Week 4	Change in objective cough rate (coughs/hours) from baseline (week minus 1) to end of Week 4, measured by the CoughMonitor smartwatch.

Secondary Outcome Measures

Name	Time	Method
Change in cough intensity from baseline to end of Week 4	Fom baseline (week minus 1) to end of week 4	Change in cough intensity from baseline to end of Week 4, including: 1. Number of cough bouts per day.; 2. Mean number of coughs within bouts.
Change in subjective impression of cough burden	From baseline to 4 weeks after starting the intervention.	Change in subjective impression of cough burden using the Patient Global Impression of Severity Scale in Chronic Cough (PGI-S) from baseline to 4 weeks after starting the intervention.; Scale from 0 to 5, higher scores mean a worse outcome.

Trial Locations

Locations (1)

Hyfe Inc.; 🇺🇸 Wilmington, Delaware, United States