Cough Management Wellness App for Refractory or Unexplained Chronic Cough

Last updated: July 9, 2025
Sponsor: Hyfe Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Allergy

Allergy (Pediatric)

Allergies & Asthma

Treatment

CoughMonitor Suite

Cough Management

Clinical Study ID

NCT07070895
CPCoMg-001
  • Ages > 21
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Age 21 or older.

  • Currently suffering from a cough that started at least 8 weeks ago that is largelyunproductive (i.e., at least 50% of the time the cough produces zero mucus thatneeds to be spit out or swallowed).

  • Normal chest X-ray or chest CT scan at some point that was prescribed specificallyfor their cough.

  • At least one physician visit for cough with standard-of-care therapy but inadequatesymptom relief.

  • Stability of treatment: willing to avoid new cough treatments during study or reportchanges if they occur.

  • Ability to comply: willing/able to wear the watch daily for the required duration ofstudy and to complete all required questionnaires.

  • Informed consent: understanding of the study procedures and agreement to comply withprotocol.

Exclusion

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, chronicbronchitis, asthma). Note: Suspected asthma without confirmed diagnosis or benefitfrom 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 withmonitoring.

  • Participation in any cough intervention study within 30 days or 5 half-lives of theintervention.

  • Major scheduled surgery during the study period.

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: CoughMonitor Suite
Phase:
Study Start date:
March 27, 2025
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Hyfe Inc.

    Wilmington, Delaware 19801
    United States

    Active - Recruiting

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