NCT07070895 Cough Management Wellness App for Refractory or Unexplained Chronic Cough
| NCT ID | NCT07070895 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hyfe Inc |
| Condition | Refractory Chronic Cough |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-03-27 |
| Primary Completion | 2025-08-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-03-27 with a primary completion date of 2025-08-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07070895 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Refractory Chronic Cough. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07070895 currently recruiting?
Yes, NCT07070895 is actively recruiting participants. Contact the research team at study@hyfe.com for enrollment information.
Where is the NCT07070895 trial being conducted?
This trial is being conducted at Wilmington, United States.
Who is sponsoring the NCT07070895 clinical trial?
NCT07070895 is sponsored by Hyfe Inc. The trial plans to enroll 20 participants.